ACAD
36.32
+0.49
+1.37%
AEMD
0.989
+0.009
+0.9082%
APRI
1.82
0.00
0.00%
ARNA
27.28
-0.03
-0.11%
ATEC
4.15
+0.03
+0.73%
CNAT
5.06
+0.05
+1.00%
CRXM
0.137
+0.034
+32.9767%
CYTX
0.5
+0.03
+7.53%
DXCM
44.78
-0.2
-0.44%
GNMK
7.92
+0.08
+1.02%
HALO
17.82
+0.05
+0.28%
ILMN
209.88
+4.7
+2.29%
INNV
0.087
0.00
0.00%
INO
6.23
-0.02
-0.32%
ISCO
1.65
+0.11
+7.14%
ISIS
57.56
0.00
0.00%
LGND
143.93
+0.58
+0.40%
LPTN
2.93
-2.93
-100.00%
MBVX
0.71
-0.03
-4.0146%
MEIP
2.68
+0.06
+2.29%
MNOV
6.14
-0.05
-0.81%
MRTX
15.75
+0.2
+1.29%
MSTX
0.13
-0.01
0.00%
NBIX
59.03
+0.07
+0.12%
NUVA
55.05
+0.48
+0.88%
ONCS
1.251
-0.039
-3.023%
ONVO
1.61
+0.21
+15.00%
OREX
1.78
-0.04
-2.20%
OTIC
3.45
-0.02
-0.72%
QDEL
41.77
-0.18
-0.43%
RCPT
231.96
0.00
0.00%
RGLS
1.21
-0.04
-3.20%
RMD
79
+0.21
+0.27%
SCIE
0
+0.00
+50.0000%
SPHS
2.33
+0.09
+4.02%
SRNE
2.8
+0.3
+12.00%
TROV
0.805
-0.004
-0.519%
VICL
2.38
0.00
0.00%
VOLC
18
0.00
0.00%
ZGNX
39.75
+0.1
+0.25%
ACAD
36.32
+0.49
+1.37%
AEMD
0.989
+0.009
+0.9082%
APRI
1.82
0.00
0.00%
ARNA
27.28
-0.03
-0.11%
ATEC
4.15
+0.03
+0.73%
CNAT
5.06
+0.05
+1.00%
CRXM
0.137
+0.034
+32.9767%
CYTX
0.5
+0.03
+7.53%
DXCM
44.78
-0.2
-0.44%
GNMK
7.92
+0.08
+1.02%
HALO
17.82
+0.05
+0.28%
ILMN
209.88
+4.7
+2.29%
INNV
0.087
0.00
0.00%
INO
6.23
-0.02
-0.32%
ISCO
1.65
+0.11
+7.14%
ISIS
57.56
0.00
0.00%
LGND
143.93
+0.58
+0.40%
LPTN
2.93
-2.93
-100.00%
MBVX
0.71
-0.03
-4.0146%
MEIP
2.68
+0.06
+2.29%
MNOV
6.14
-0.05
-0.81%
MRTX
15.75
+0.2
+1.29%
MSTX
0.13
-0.01
0.00%
NBIX
59.03
+0.07
+0.12%
NUVA
55.05
+0.48
+0.88%
ONCS
1.251
-0.039
-3.023%
ONVO
1.61
+0.21
+15.00%
OREX
1.78
-0.04
-2.20%
OTIC
3.45
-0.02
-0.72%
QDEL
41.77
-0.18
-0.43%
RCPT
231.96
0.00
0.00%
RGLS
1.21
-0.04
-3.20%
RMD
79
+0.21
+0.27%
SCIE
0
+0.00
+50.0000%
SPHS
2.33
+0.09
+4.02%
SRNE
2.8
+0.3
+12.00%
TROV
0.805
-0.004
-0.519%
VICL
2.38
0.00
0.00%
VOLC
18
0.00
0.00%
ZGNX
39.75
+0.1
+0.25%
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Reimbursement Specialist

September 25, 2017 – 11:16 am

Bio-tech company located in San Diego needs a Collections / Reimbursement Specialist to catch up on backlog of work. Company offers an excellent company culture, professional working enviorment, and brand new building located in La Jolla. 3 Month Contract

UC San Diego Researchers Explain the Mechanism of Asexual Reproduction in Freshwater Flatworms

September 25, 2017 – 10:28 am

Freshwater planarians, found around the world and commonly known as “flatworms,” are famous for their regenerative prowess. Through a process called “fission,” planarians can reproduce asexually by simply tearing themselves into two pieces— a head and a tail—which then go on to form two new worms within about a week.

Aggressively reduced radiation therapy for HPV-related throat cancer achieves similar control rates with fewer side effects

September 25, 2017 – 10:00 am

Phase II trial indicates viability of half the standard dose for appropriately selected patients with oropharynx cancer following surgery

SAN DIEGO, Sept. 25, 2017 /PRNewswire/ — For certain patients with oropharyngeal cancer caused by the human papilloma virus (HPV), an aggressive reduction of radiation therapy after surgery may provide excellent cancer control while simultaneously reducing post-treatment side effects, improving quality of life and lowering treatment costs, according to research presented today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO). Patients in the phase II clinical trial received half the standard radiation dose but achieved equally high cure rates at two years following treatment.

Standard treatment for oropharyngeal squamous cell carcinoma (OPSCC) can include surgery to remove the cancer followed by radiation therapy with or without chemotherapy. While cure rates are excellent following therapy, treating the sensitive throat and neck regions often causes serious and potentially life-altering side effects.

Quality of life considerations have become even more salient in the past several decades, as today’s average OPSCC patient is younger and will live a longer time with any side effects of treatment. Between 1988 and 2004, the rates of HPV‐associated OPSCC more than doubled, while the rates of HPV‐negative disease—which is typically caused by smoking and alcohol consumption—dropped by half. HPV-related disease also is biologically more responsive to radiation and chemotherapy, leading to high cure rates for these patients.

“The profile of the typical oropharynx cancer patient has changed, which means that our approach to treating this disease needs to change, as well,” said Daniel Ma, MD, lead author of the study and an assistant professor of radiation oncology at the Mayo Clinic in Rochester, Minnesota. “Several research groups are pursuing an incremental approach to de-escalating treatment, such as using 15 percent less radiation dose. Our trial took a different approach—testing whether we could cut the dose by half. Our findings indicate that this more aggressive approach toward treatment reduction can be viable for appropriately selected patients.”

MC1273 was a single-arm phase II trial for HPV-related OPSCC testing clinical outcomes and quality of life with a de-escalated course of radiation therapy following surgery to remove the disease. Patients received two weeks of twice-daily radiation therapy to the oropharynx for a total dose of 30-36 Gray (Gy), a 50 percent reduction of the standard radiation dose of 60-66 Gy.  Patients also received two courses of chemotherapy (docetaxel 15 mg/m2), delivered on days one and eight. The 43 patients with extracapsular extension (ECE), a marker of particularly aggressive disease, received an additional, simultaneous radiation boost to the areas with ECE, for a total dose (including primary treatment) of 36 Gy.

Eighty patients were accrued between September 2013 and June 2016 with all patients completing treatment. Eligible patients included those with HPV-related OPSCC who had no evidence of residual disease following surgery and a minimal smoking history (e.g., less than one pack per day for 10 years or less).  The median patient age was 60.5 years (range 25-77 years). All patients had stage III or IV disease. The median follow-up for this report was 24 months (range 12-46 months).

At a median follow-up of two years after de-escalated treatment, the rate of tumor control in the oropharynx and surrounding region was 95 percent. Of the 80 patients in the trial, three experienced a local recurrence and one patient experienced a regional recurrence. Disease-free survival (DFS) following the dose-reduced treatment was 89 percent. By comparison, the RTOG 0234 clinical trial reported a two-year DFS rate of 86.4 percent for patients with HPV-related cancers.

Grade 2 or higher side effects were reported in one percent of patients at one year following treatment and ten percent at two years following treatment. By comparison, studies of adjuvant radiation for OPSCC generally report rates of late grade 2 or higher side effects at more than 50 percent (e.g., 55% on RTOG 0234). No patients had grade 3+ toxicity at one year or two years following treatment. Fourteen patients (18%) experienced cumulative grade 3+ toxicity within three months of treatment; all instances resolved by six months post-treatment. One additional patient experienced a temporary grade 4 event related to a chemotherapy reaction.

Patients’ ability to swallow improved slightly at one year following radiation therapy compared to pre-treatment (p = 0.03). Swallowing function was measured using the Modified Barium Swallow Impairment Profile (MBSImP). Importantly, no patients needed to have a feeding tube placed during treatment.

Patient’s quality of life largely improved or did not change following treatment, except for dry mouth. Patients reported somewhat worse salivary flow following treatment (p < 0.0001), as measured by the University of Michigan’s Xerostomia QOL scale (XeQOLS). However, none of the other quality of life scales declined significantly—including the Functional Assessment of Cancer Therapy – Head and Neck Version 4 (FACT H&N), the EuroQol EQ-5D and the European Organisation for Research and Treatment of Cancer instrument for head and neck cancer (EORTC-HN). Each measure was assessed prior to radiation therapy and again at one, three, 12 and 24 months following treatment.

“Side effects with dose-reduced treatment were dramatically less than what we usually see in treatment of adjuvant radiation therapy for oropharynx cancer. For example, no patients in this trial needed a feeding tube placed, whereas close to a third of patients had feeding tubes placed with traditional doses on other recent clinical trials,” explained Dr. Ma.

“The shorter course of treatment also has practical value for patients. If a patient has 20 twice-daily sessions instead of 30 daily treatment sessions, their financial cost is reduced by a third, and time away from work or family is reduced by a third—but the likelihood of cure remains the same.”

While the results are promising, Dr. Ma emphasized that findings from a randomized study directly comparing the dose-reduced treatment with traditional treatment are needed before the new approach can be adopted widely.

“These results will require confirmation in a randomized trial, and this treatment approach should be considered investigational until confirmed in a phase III study, such as the ongoing multi-institutional DART-HPV trial that is currently open for patient accrual,” he said.

The abstract, “Two-year results for MC1273, a phase II evaluation of aggressive dose de-escalation for adjuvant chemoradiation in HPV+ oropharynx squamous cell carcinoma (OPSCC),” will be presented in detail during a news briefing and the late-breaking abstracts special session at ASTRO’s 59th Annual Meeting in San Diego (full details below). To schedule an interview with Dr. Ma and/or outside experts in head and neck cancer, contact ASTRO’s media relations team on-site at the San Diego Convention Center September 24 through 27, by phone at 703-286-1600 or by email at press@astro.org.

ATTRIBUTION TO THE AMERICAN SOCIETY OF RADIATION ONCOLOGY (ASTRO) ANNUAL MEETING REQUESTED IN ALL COVERAGE.

This news release contains additional and/or updated information from the study author(s). Full original abstract and author disclosures available from press@astro.org or at www.astro.org/annualmeeting.

Study Presentation Details

  • News Briefing: Monday, September 25, 11:00 a.m.12:00 p.m. Pacific time, San Diego Convention Center, room 24C, webcast: http://www.bit.do/astro17-2
  • Scientific Session: Tuesday, September 26, 7:45 – 9:15 a.m. Pacific time, San Diego Convention Center, room 5A

Resources on Head and Neck Cancer and Radiation Therapy

ABOUT ASTRO’S ANNUAL MEETING
ASTRO’s 59th Annual Meeting, the world’s largest scientific meeting in radiation oncology, will be held September 24-27, 2017, at the San Diego Convention Center. The 2017 Annual Meeting is expected to attract more than 11,000 attendees from across the globe, including oncologists from all disciplines and members of the entire radiation oncology team. More than 2,800 abstracts sharing results from clinical trials and other research studies will be presented in conjunction with educational sessions and keynote addresses that underscore the meeting’s theme, “The Healing Art and Science of Radiation Oncology.” Led by ASTRO President Brian Kavanagh, MD, MPH, FASTRO, the 2017 meeting will feature keynote addresses from Richard D. Zane, MD, FAAEM, Chief Innovation Officer for the University of Colorado Health System; Lucy Kalanithi, MD, FACP, widow of Paul Kalanithi, MD, the best-selling author of “When Breath Becomes Air,” with Heather Wakelee, MD, Paul’s oncologist; and Vinay K. Prasad, MD, MPH, an assistant professor of medicine at the Oregon Health & Science University. During the four-day meeting, more than 200 exhibitors will demonstrate cutting-edge technology and medical device innovations for radiation oncology. Visit us online for more information about ASTRO’s 59th Annual Meeting or press opportunities at the meeting.

ABOUT ASTRO
The American Society for Radiation Oncology (ASTRO) is the world’s largest radiation oncology society, with more than 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. The Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes three medical journals, International Journal of Radiation Oncology • Biology • Physics (www.redjournal.org), Practical Radiation Oncology (www.practicalradonc.org) and Advances in Radiation Oncology (www.advancesradonc.org); developed and maintains an extensive patient website, RT Answers (www.rtanswers.org); and created the Radiation Oncology Institute (www.roinstitute.org), a nonprofit foundation to support research and education efforts around the world that enhance and confirm the critical role of radiation therapy in improving cancer treatment. To learn more about ASTRO, visit www.astro.org and follow us on our blog, Facebook and Twitter.  

Contact: Liz Gardner
703-286-1600
liz.gardner@astro.org

Leah Kerkman Fogarty
703-839-7336
leah.fogarty@astro.org  

 

View original content with multimedia:http://www.prnewswire.com/news-releases/aggressively-reduced-radiation-therapy-for-hpv-related-throat-cancer-achieves-similar-control-rates-with-fewer-side-effects-300524718.html

SOURCE American Society for Radiation Oncology

Accelerated breast radiation therapy following mastectomy shortens treatment time while maintaining tumor control

September 25, 2017 – 10:00 am

Clinical trial for intermediate-stage breast cancer finds equivalent five-year local/regional control following hypofractionated radiation that reduced treatment from five to three weeks

SAN DIEGO, Sept. 25, 2017 /PRNewswire/ — Radiation therapy following mastectomy for intermediate-stage, high-risk breast cancer can be shortened from five to three weeks while maintaining tumor control rates in the breast and surrounding region that are equivalent to conventional treatment, according to research presented today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO).

Five-year results of a Chinese clinical trial with more than 800 post-mastectomy breast cancer patients confirmed that tumor recurrence rates following 15 daily fractions of radiation delivered over three weeks were not inferior to those following 25 fractions. Patients also experienced fewer side effects following accelerated treatment, indicating that hypofractionated radiation following mastectomy is a safe and effective treatment for locally advanced disease.

“Patients with invasive breast cancer receive radiation therapy after tumor-removal surgery to destroy any remaining cancer cells and prevent this very aggressive disease from returning,” said Shulian Wang, MD, one of the study’s lead authors and a radiation oncologist at the Chinese Academy of Medical Sciences in Beijing, China.

“This trial demonstrates that we can safely accelerate adjuvant radiation therapy and reduce treatment time by two weeks. This option makes treatment more convenient for patients, reduces medical expenses and allows providers to treat more patients with limited resources.”

Of the 820 patients with high-risk breast cancer who enrolled in the trial from 2008 to 2016, 810 were eligible for analysis. The median age was 49 years (range 24-74 years). Nearly all patients (93.9%) had stage III breast cancer, and the remaining 6.1 percent had stage II disease.

All patients underwent mastectomy and received chemotherapy consisting of taxanes and/or anthracycline-based regimens (specifically, 88.6% taxanes and anthracycline, 8.9% taxanes-based, 1.9% anthracycline-based and 0.6% unknown), and some patients received trasuzumab targeted therapy (16.8%) and/or hormonal therapy (76.5% of all patients; 94.5% of those eligible). Patient and disease characteristics did not differ significantly between the treatment groups.

Following mastectomy, patients were randomly assigned in even proportions to receive either accelerated (i.e., hypofractionated) or standard (i.e., conventionally fractionated) external beam radiation therapy to the chest wall and supra-infraclavicular nodal region. The accelerated regimen consisted of 43.5 Gray (Gy) delivered in 15 fractions over three weeks, and the standard regimen consisted of 50 Gy delivered in 25 fractions over five weeks. Treatment was delivered via two-dimensional radiation therapy. Median follow-up for surviving patients was 55 months, with an interquartile range of 36 to 79 months.

At five years following accelerated treatment, the rate of locoregional recurrence, where disease returns in the breast or region near the breast, was noninferior to the rate for standard treatment. Locoregional recurrence rates were 8.3 percent following accelerated treatment and 8.1 percent following standard treatment (Hazard Ratio (HR) = 1.10, 95% CI 0.67-1.83), with a difference of 0.2 percent (95% CI = -4.1 to 4.5).  

Among all patients, the five-year overall survival rate was 84.4 percent, and the disease-free survival rate was 72.7 percent. Five-year overall survival rates were 83.2 percent following accelerated treatment and 85.6 percent following standard treatment (HR = 1.13, 95% CI 0.78-1.62). Five-year disease-free survival rates were 74.6 percent for the accelerated treatment arm and 70.7 percent following standard treatment (HR = 0.88, 95% CI 0.67-1.16).

Rates of distant metastases, where a patient develops tumors outside the region of the original tumor, were 23.2 percent and 26.2 percent at five years for accelerated and standard treatment, respectively (HR = 0.90, 95% CI 0.67-1.20). Survival and recurrence rates were calculated using the Kaplan-Meier method and analyzed using Cox regression models.

The two cohorts did show some differences in terms of treatment-related side effects. Fewer patients in the accelerated treatment group experienced grade 3 acute skin toxicity (3.5% versus 7.8% of standard-treatment patients; p = 0.008). Rates between the treatment arms were similar for symptomatic radiation pneumonitis, lymphedema and shoulder disorder, and no patients experienced brachial plexopathy. Toxicity rates were compared using Chi-square tests.

“Clinicians have seen clear benefits with accelerated radiation therapy to the whole breast after breast-conserving surgery but questions remain about its safety and effectiveness with treating nodal regions. Our trial demonstrates a similar benefit for intermediate-stage breast cancer after mastectomy, in that we reduced treatment time from five weeks to three weeks while preserving high rates of tumor control and tolerability,” said Dr. Wang.

“The accelerated approach also has practical value for patients. With fewer treatment sessions, patients spend less time away from work and family, enjoy lower transportation costs and, as our findings show, experience fewer side effects.”

The abstract, “Hypofractionated radiotherapy after mastectomy for the treatment of high-risk breast cancer: 5-year follow up result of a randomized trial,” will be presented in detail during a news briefing and the plenary session at ASTRO’s 59th Annual Meeting in San Diego (full details below). To schedule an interview with Dr. Wang and/or outside experts in breast cancer, contact ASTRO’s media relations team on-site at the San Diego Convention Center September 24 through 27, by phone at 703-286-1600 or by email at press@astro.org.

ATTRIBUTION TO THE AMERICAN SOCIETY OF RADIATION ONCOLOGY (ASTRO) ANNUAL MEETING REQUESTED IN ALL COVERAGE.

This news release contains additional and/or updated information from the study author(s). Full original abstract and author disclosures available on the final page of this release.

Study Presentation Details

  • News Briefing: Monday, September 25, 11:00 a.m.12:00 p.m. Pacific time, San Diego Convention Center, room 24C, webcast: http://www.bit.do/astro17-2
  • Scientific Session: Plenary, Monday, September 25, 2:15 – 3:45 p.m. Pacific time, San Diego Convention Center, Ballroom 20

Resources on Breast Cancer and Radiation Therapy

ABOUT ASTRO’S ANNUAL MEETING
ASTRO’s 59th Annual Meeting, the world’s largest scientific meeting in radiation oncology, will be held September 24-27, 2017, at the San Diego Convention Center. The 2017 Annual Meeting is expected to attract more than 11,000 attendees from across the globe, including oncologists from all disciplines and members of the entire radiation oncology team. More than 2,800 abstracts sharing results from clinical trials and other research studies will be presented in conjunction with educational sessions and keynote addresses that underscore the meeting’s theme, “The Healing Art and Science of Radiation Oncology.” Led by ASTRO President Brian Kavanagh, MD, MPH, FASTRO, the 2017 meeting will feature keynote addresses from Richard D. Zane, MD, FAAEM, Chief Innovation Officer for the University of Colorado Health System; Lucy Kalanithi, MD, FACP, widow of Paul Kalanithi, MD, the best-selling author of “When Breath Becomes Air,” with Heather Wakelee, MD, Paul’s oncologist; and Vinay K. Prasad, MD, MPH, an assistant professor of medicine at the Oregon Health & Science University. During the four-day meeting, more than 200 exhibitors will demonstrate cutting-edge technology and medical device innovations for radiation oncology. Visit us online for more information about ASTRO’s 59th Annual Meeting or press opportunities at the meeting.

ABOUT ASTRO
The American Society for Radiation Oncology (ASTRO) is the world’s largest radiation oncology society, with more than 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. The Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes three medical journals, International Journal of Radiation Oncology • Biology • Physics (www.redjournal.org), Practical Radiation Oncology (www.practicalradonc.org) and Advances in Radiation Oncology (www.advancesradonc.org); developed and maintains an extensive patient website, RT Answers (www.rtanswers.org); and created the Radiation Oncology Institute (www.roinstitute.org), a nonprofit foundation to support research and education efforts around the world that enhance and confirm the critical role of radiation therapy in improving cancer treatment. To learn more about ASTRO, visit www.astro.org and follow us on our blog, Facebook and Twitter.

Contact: Liz Gardner
703-286-1600
liz.gardner@astro.org 

Leah Kerkman Fogarty
703-839-7336
leah.fogarty@astro.org 

 

View original content with multimedia:http://www.prnewswire.com/news-releases/accelerated-breast-radiation-therapy-following-mastectomy-shortens-treatment-time-while-maintaining-tumor-control-300524717.html

SOURCE American Society for Radiation Oncology

Senior Systems Engineer (Full Time) – ManagedLab Services – San Diego, CA

September 25, 2017 – 9:15 am

Systems Engineer (SSE) is responsible for the design and implementation of customer solutions. The SSE also provides support to department technicians and is…From ManagedLab Services – Mon, 25 Sep 2017 17:15:39 GMT – View all San Diego, CA jobs

Director, Technical Operations and Analytical Development – Synthetic Genomics, Inc. – La Jolla, CA

September 25, 2017 – 9:05 am

Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity….From Synthetic Genomics, Inc. – Mon, 25 Sep 2017 17:05:06 GMT – View all La Jolla, CA jobs

Renova Therapeutics leadership speaking at Cell & Gene Therapy CEO forum and Boulder Peptide Symposium

September 25, 2017 – 7:30 am

SAN DIEGO, Sept. 25, 2017 /PRNewswire-USNewswire/ — Renova™ Therapeutics, a biotechnology company developing gene and peptide-based treatments for cardiovascular and metabolic diseases, announced that the company’s CEO and Co-founder, Jack W. Reich, Ph.D., is participating on a panel at the Cell & Gene Therapy CEO forum in Boston, and its Vice President of Preclinical Research and Pharmacology, Peter Gengo, Ph.D., is speaking at the Boulder Peptide Symposium in Boulder, Colorado. Both events are occurring on September 25.

Cell & Gene Therapy CEO

Boston Biotech Conferences’ Cell & Gene Therapy CEO is an off-the-record networking forum that brings together CEOs and decision-makers in cell therapy, gene therapy and regenerative medicine. Dr. Reich will be participating on a discussion panel on overcoming technology challenges in cell and gene therapy companies.

“Since the inception of gene therapy, we’ve seen tremendous progress in the field over the last few decades – but no disruptive medical innovation is without its challenges,” said Dr. Reich, who was previously co-founder of the first gene therapy company, Viagene, and co-founder of Collateral Therapeutics, the first gene therapy company focused on cardiovascular disease. “With gene therapy, we’re looking at changing the way some major chronic diseases are treated in an unprecedented manner. There are lessons we’ve all learned along the way that are worth sharing.”

The forum comprises intimate discussion panels, keynotes and fireside chats with thought leaders debating business model efficiencies, financing, regulatory issues, market access and reimbursement, novel partnerships, manufacturing and delivery challenges. Healthcare investors and leading researchers also participate.

The meeting also features speakers from GlaxoSmithKline, Novartis and Pfizer, among others. The panel on overcoming technology challenges will take place at 11:30 a.m. EST.

Boulder Peptide Symposium

The Boulder Peptide Symposium is an annual event in which key decision leaders from both industry and academia come together to discuss the future of peptide therapeutics.

An accomplished biochemical analytical pharmacologist, Dr. Gengo is presenting the Renova Therapeutics gene and peptide therapy programs at the symposium. In particular, he will provide an overview of the company’s discovery work on peptides as potential treatment options for heart failure as well as type 2 diabetes.

“Complementing the Renova Therapeutics gene-based product candidate portfolio are peptide-based programs that can help impact the symptoms and progression of major chronic diseases,” said Dr. Gengo. “Right now we’re looking at identifying peptide variants that could become subcutaneous or intravenous infusion therapies to ease suffering of heart failure or type 2 diabetes patients.”

Dr. Gengo joined Renova Therapeutics in May to direct and execute the company’s preclinical objectives, including developing a stresscopin-based peptide product candidate program. Along with Waldemar Radziszewski, MD, Ph.D., Renova’s Executive Vice President of Translational Research, Dr. Gengo worked on the stresscopin development program for acute heart failure while at Janssen Pharmaceuticals.

Dr. Gengo’s presentation will take place on September 25, the first day of the three-day symposium.

About Renova Therapeutics
Renova Therapeutics is developing definitive, one-time gene therapies and peptide infusion treatments to restore the health of people suffering from chronic diseases. The first indications the company is pursuing are gene therapy treatments for heart failure and type 2 diabetes, two of the most common and devastating chronic diseases in the world. The company’s lead product, RT-100, is a treatment that delivers a therapeutic gene directly to the heart during a routine outpatient procedure and has the potential to increase heart function in millions of patients with heart failure. The company’s product pipeline also includes a groundbreaking gene therapy in preclinical stage for sufferers of type 2 diabetes, as well as a peptide infusion therapy for the treatment of acute decompensated heart failure. Renova Therapeutics was founded in 2009 and is led by an experienced management team in biopharmaceuticals and gene therapy. For additional information about the company, please visit www.renovatherapeutics.com.

About the Boston Biotech Conferences
The Boston Biotech Conferences (BBC)’s mission is to build a vibrant community of bio-pharma leaders, which will help to drive innovation in biotech, and bring important drugs to patients more quickly. The conferences are exclusive, thought-leader forums for senior bio-pharma executives. Each conference is highly interactive and co-hosted by healthcare industry leaders to foster discussions and facilitate information-sharing, networking and corporate development within the bio-pharma community. The meetings are invitation-only, off-the-record forums that bring together the past, present and future leaders in the healthcare community to network, exchange ideas and share insights into the industry’s challenges and opportunities. For more information, visit http://www.bbbiotechconference.com.

About the Boulder Peptide Symposium
The Boulder Peptide Symposium seeks to bring together key decision leaders from both industry and academia to discuss the future of peptide therapeutics. Peptide therapeutics are potent and highly selective yet their development into effective treatments can be challenged by limited delivery routes, product stability, manufacturing challenges and an evolving regulatory landscape. BPS is the key forum where these challenges will be identified, discussed, and one day—addressed.

 

View original content with multimedia:http://www.prnewswire.com/news-releases/renova-therapeutics-leadership-speaking-at-cell–gene-therapy-ceo-forum-and-boulder-peptide-symposium-300524554.html

SOURCE Renova Therapeutics

Breast cancer patients largely find radiation therapy experience better than expected

September 25, 2017 – 6:45 am

Survey of breast cancer clinic patients finds short- and long-term side effects often better than anticipated; nine in ten women say radiation “less scary” than expected

SAN DIEGO, Sept. 25, 2017 /PRNewswire/ — A new survey finds breast cancer patients’ actual radiation therapy experiences largely exceeded their expectations. The survey, which addressed the fears and misconceptions regarding radiation therapy for breast cancer, found that more than three-fourths of the breast cancer patients surveyed found their experiences with radiation therapy, including overall and specific long-term and short-term side effects, to be less “scary” than anticipated, according to research presented today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO).

“Radiation oncologists know firsthand that our patients come in with fears and sometimes misconceptions. Unlike many other treatments and fields of medicine, it is very hard to imagine what radiation therapy is like,” said Narek Shaverdian, MD, lead author of the study and a radiation oncology resident at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). “Still, it is surprising to find that upwards of 90 percent of women surveyed agree that if future patients knew the reality of the radiation therapy experience, they would be less afraid of treatment.

“Advances in radiation therapy technologies over the past several decades and the increased use of hypofractionation—where radiation is given in larger doses across fewer sessions—have afforded patients more convenient treatment options, as well as lower toxicity rates in many situations,” said Dr. Shaverdian.

“Our study shows that women who received modern breast radiation therapy overwhelmingly found the treatment experience far better than expected. The negative stories out there are frightening and pervasive, but they generally are not reflective of the actual experience,” said Susan McCloskey, MD, MSHS, assistant professor at the David Geffen School of Medicine at UCLA, Director of the Breast Service at UCLA Radiation Oncology and senior author of the study.

Surveys were sent to all patients who received treatment for breast cancer at a UCLA-affiliated multidisciplinary breast cancer clinic between 2012 and 2016. Eligible patients had six or more months of follow-up and were without tumor recurrence. Sixty-five percent of these 502 patients returned surveys, and study findings are based on these 327 responses. The median age of survey respondents was 59 years (range 28-89 years).

Patients represented various disease stages; 18 percent had stage 0 breast cancer; 38 percent stage I; 34 percent stage II; and 9 percent stage III. Eighty two percent underwent breast conserving surgery, 13% had axillary dissection, 37% received chemotherapy, and 70% received endocrine therapy. All patients received radiation therapy (RT), delivered as either standard whole-breast RT with or without regional nodal coverage, hypofractionated whole-breast RT, post-mastectomy RT, or partial breast RT.

Patients completed the survey a median of 31 months (range 6-61 months) after completing radiation therapy. Survey questions assessed fears and beliefs about breast cancer treatment and side effects, as well as how the actual experience compared to initial expectations. Specifically, patients were asked if the treatment experience, short-term side effects and long-term side effects were as expected, worse than expected or better than expected.

Nine in ten patients (90%) found the actual experience of breast radiation therapy to be “less scary” than anticipated. Overall short-term and long-term side effects of radiation were better than expected or as expected for 83 percent and 84 percent of respondents, respectively. Patients also reported that side effects were less severe than or as expected for short-term breast pain (75%), skin changes (61%) and fatigue (78%), as well as for long-term appearance changes (85%), breast pain (79%), breast size changes (73%) and breast textural changes (70%).

More than two-thirds (68%) of these breast cancer patients reported that they had little to no prior knowledge of radiation therapy at the time of their diagnosis, yet nearly half (47%) also shared that they had previously read or heard “frightening” stories of serious side effects from radiation therapy. Nearly all women surveyed (94%) responded that they were initially fearful of receiving radiation therapy. The most common initial fears related to radiation therapy were concerns about damage to internal organs (40%), skin burning (24%) and becoming radioactive (7%). Very few patients found confirmation for these negative stories during treatment, however; among 327 respondents, eight women (3%) found the negative stories they previously read about radiation therapy to be true and six women (2%) found the negative stories they heard from family and friends to be true. The trend of finding negative stories to be largely untrue was even more pronounced among patients who underwent breast conservation therapy. Nine in ten survey respondents agreed that “After treatment, I now realize that radiation therapy is not as bad as they say it is,” and/or that “If future patients knew the ‘real truth’ about radiation therapy, they would be less scared about treatment.”

“We hope that these data, which reflect the voices of past breast cancer patients, can help to counsel future patients and their physicians on the actualities of the modern breast radiation therapy experience,” said Dr. Shaverdian. “Patients who have received this treatment provide the most credible account of its actual impact, and their accounts show that outdated, negative stereotypes of breast radiation are almost universally found to be untrue.”

The abstract, “The patient’s perspective on breast radiation therapy: initial fears and expectations versus reality,” will be presented in detail during a news briefing and an oral abstract session at ASTRO’s 59th Annual Meeting in San Diego (full details below). To schedule an interview with Dr. Shaverdian and/or outside experts in breast cancer, contact ASTRO’s media relations team on-site at the San Diego Convention Center, September 24 through 27, by phone at 703-286-1600 or by email at press@astro.org.

ATTRIBUTION TO THE AMERICAN SOCIETY OF RADIATION ONCOLOGY (ASTRO) ANNUAL MEETING REQUESTED IN ALL COVERAGE.

This news release contains additional and/or updated information from the study author(s). Full original abstract and author disclosures available from press@astro.org or at www.astro.org/annualmeeting.

Study Presentation Details

  • Scientific Session: Monday, September 25, 7:45 – 9:00 a.m. Pacific time, San Diego Convention Center, room 5B
  • News Briefing: Tuesday, September 26, 1:00 – 2:00 p.m. Pacific time, San Diego Convention Center, room 24C, webcast: http://www.bit.do/astro17-3

Resources on Breast Cancer and Radiation Therapy

ABOUT ASTRO’S ANNUAL MEETING
ASTRO’s 59th Annual Meeting, the world’s largest scientific meeting in radiation oncology, will be held September 24-27, 2017, at the San Diego Convention Center. The 2017 Annual Meeting is expected to attract more than 11,000 attendees from across the globe, including oncologists from all disciplines and members of the entire radiation oncology team. More than 2,800 abstracts sharing results from clinical trials and other research studies will be presented in conjunction with educational sessions and keynote addresses that underscore the meeting’s theme, “The Healing Art and Science of Radiation Oncology.” Led by ASTRO President Brian Kavanagh, MD, MPH, FASTRO, the 2017 meeting will feature keynote addresses from Richard D. Zane, MD, FAAEM, Chief Innovation Officer for the University of Colorado Health System; Lucy Kalanithi, MD, FACP, widow of Paul Kalanithi, MD, the best-selling author of “When Breath Becomes Air,” with Heather Wakelee, MD, Paul’s oncologist; and Vinay K. Prasad, MD, MPH, an assistant professor of medicine at the Oregon Health & Science University. During the four-day meeting, more than 200 exhibitors will demonstrate cutting-edge technology and medical device innovations for radiation oncology. Visit us online for more information about ASTRO’s 59th Annual Meeting or press opportunities at the meeting.

ABOUT ASTRO
The American Society for Radiation Oncology (ASTRO) is the world’s largest radiation oncology society, with more than 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. The Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes three medical journals, International Journal of Radiation Oncology • Biology • Physics (www.redjournal.org), Practical Radiation Oncology (www.practicalradonc.org) and Advances in Radiation Oncology (www.advancesradonc.org); developed and maintains an extensive patient website, RT Answers (www.rtanswers.org); and created the Radiation Oncology Institute (www.roinstitute.org), a nonprofit foundation to support research and education efforts around the world that enhance and confirm the critical role of radiation therapy in improving cancer treatment. To learn more about ASTRO, visit www.astro.org and follow us on our blog, Facebook and Twitter.

Contact: Liz Gardner
703-286-1600
liz.gardner@astro.org 

Leah Kerkman Fogarty
703-839-7336
leah.fogarty@astro.org

 

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SOURCE American Society for Radiation Oncology

Viking Therapeutics to Host Key Opinion Leader Event to Discuss Musculoskeletal Therapeutics in Hip Fracture and Other Settings

September 25, 2017 – 3:30 am

Presentation and Webcast to Highlight Novel SARM VK5211 and Potential Therapeutic Applications

SAN DIEGO, Sept. 25, 2017 /PRNewswire/ — Viking Therapeutics, Inc. (“Viking”) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that it will host a key opinion leader (KOL) presentation and webcast to highlight the current unmet need in post-fracture therapy and discuss the company’s lead program VK5211 for the treatment of patients following hip fracture surgery.  The event details are as follows:

Date: 

Monday, October 9, 2017

Time: 

10:00am – 12:00pm

Location: 

Michelangelo Hotel

152 W. 51st Street @ 7th Avenue

Roman Room

The event will feature presentations from four speakers, each with significant experience in the development of novel musculoskeletal therapeutics or in the treatment of hip and other fracture patients:

  • Keith Marschke, Ph.D., VP, Biology, Ligand Pharmaceuticals
  • Jay Magaziner, Ph.D., Epidemiology and Biostatistics Professor and Chair, Department of Epidemiology and Public Health, University of Maryland School of Medicine
  • Neil Binkley, M.D., Professor, Department of Medicine – Geriatrics; Co-Director, Osteoporosis Clinical Center and Research Program, Associate Director, Institute on Aging, University of Wisconsin School of Medicine and Public Health
  • Jack Guralnik, M.D., Ph.D., MPH, Professor, Department of Epidemiology and Public Health, University of Maryland School of Medicine

A light lunch will be served at conclusion of the event.

Viking recently announced that enrollment has been completed in the company’s ongoing Phase 2 clinical trial of VK5211 in patients recovering from hip fracture surgery.  VK5211, the company’s lead program for muscle and bone disorders, is an orally available, non-steroidal selective androgen receptor modulator (SARM) designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate.  The company believes these characteristics may provide important benefits to patients recovering from hip fracture. 

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery.  A total of 108 patients have been randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks.  The study’s primary endpoint will evaluate the effects of VK5211 on lean body mass after 12 weeks of treatment.  Secondary and exploratory objectives include assessments of functional performance, quality-of-life, and activities of daily living, as well as safety, tolerability and pharmacokinetics.  Viking expects to announce results from this trial in the fourth quarter.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Space is limited, please RSVP in advance to attend. To RSVP, please contact Stephanie Diaz at Vida Strategic Partners at sdiaz@vidasp.com.

A live and archived webcast of the event will be available on the Investors section of the company’s website at http://ir.vikingtherapeutics.com/webcasts-and-presentations

About VK5211
VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) in Phase 2 development for the treatment of patients recovering from non-elective hip fracture surgery.  VK5211 belongs to a family of novel orally available, non-steroidal SARM compounds based on tissue-specific gene expression and other functional, cell-based technologies.  Viking believes that VK5211 has the potential to produce the therapeutic benefits of testosterone with improved safety, tolerability and patient acceptance due to a tissue-selective mechanism of action and an oral route of administration.  In Phase 1 clinical trials, VK5211 demonstrated statistically significant increases in lean body mass among treated subjects following 21 days of treatment.  In a pre-clinical model of osteoporosis, VK5211 demonstrated improvements in bone mineral density, bone mineral content, bone strength, and other measures.

About Viking Therapeutics, Inc. 
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders.  The company’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives.  Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.  The company’s clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist in Phase 2 development for hypercholesterolemia and fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes.  Viking is also developing novel and selective agonists of the thyroid beta receptor for adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.

Follow Viking on Twitter @Viking_VKTX.

Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking’s expectations regarding its development activities, timelines and milestones, as well as the company’s goals and plans regarding VK2809 and VK2809’s prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking’s product candidate development activities and clinical trials, including those for VK2809; risks that prior clinical and pre-clinical results may not be replicated; and risks regarding regulatory requirements, among others. These forward-looking statements speak only as of the date hereof.  Viking disclaims any obligation to update these forward-looking statements.

 

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SOURCE Viking Therapeutics, Inc.

SI-BONE, Inc. Announces Publication of iMIA – a 2nd Multicenter Randomized Controlled Trial of the iFuse Implant System® vs Conservative Care

September 25, 2017 – 3:00 am

One-Year Results for more than 100 patients at 9 Hospitals in 4 European Countries Show that the iFuse Implant(TM) is Safe and More Effective than Conservative Care

SAN JOSE, Calif., Sept. 25, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company which pioneered the use of the iFuse Implant System® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of one-year results from iMIA (iFuse Implant System Minimally Invasive Arthrodesis; ClinicalTrials.gov ID NCT01741025).  iMIA is a randomized controlled trial, conducted at 9 hospitals in 4 countries in Europe, that assessed the safety and effectiveness of SI joint fusion with the iFuse Implant compared to conservative management (CM) in patients with chronic SI joint dysfunction.  This Level 1 study was published in Pain Physician, the official journal of the American Society of Interventional Pain Physicians and titled 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint1.  The study showed that for patients with chronic low back pain (LBP) due to certain types of SI joint dysfunction, minimally invasive SI joint fusion with the iFuse Implant was safe and more effective than CM in relieving pain, reducing disability, and improving patient function and quality of life at one year.  The full article can be found at the following link: http://www.painphysicianjournal.com/current/pdf?article=NDYwOQ%3D%3D

The study included 109 subjects enrolled between June, 2013 and May, 2015 and follow-up for this publication extends through October, 2016.  Mean age was 48.1 years, 75 subjects (72.8%) were women and mean SI joint pain duration was 4.7 years.  Most (72.8%) had undergone prior SI joint steroid injections, a minority (16.5%) had had prior radiofrequency ablation and about 1/3 (35.9%) had undergone prior lumbar fusion, a known risk factor for SI joint pain.  Patients in the surgical arm of the study were treated with the iFuse Implant, which has been commercially available in the United States since 2009.

As shown in the figures below, at one year, mean LBP improved by 41.6 VAS points (0 – 100 VAS pain scale) in the SI joint fusion group compared to 14.0 points in the CM group (Figure 1), and the mean Oswestry Disability Index (ODI) improved by 25.0 points in the SI joint fusion group compared to 8.7 points in the CM group (Figure 2).  Also, mean improvements in leg pain and EQ-5D-3L were large after SI joint fusion and superior to those after CM.  CM subjects were allowed to cross over to SI joint fusion after six months and subjects who crossed over to surgical treatment had no pre-crossover improvement in pain and ODI scores.  After crossover, improvements in most measures were as large as those patients originally assigned to SI joint fusion.

“It’s been most gratifying to be a part of this important trial to help identify the value and benefits of the use of the iFuse Implant for SI joint patients who no longer benefit from conservative therapies,” said Bengt Sturesson, MD, from Ängelholm Hospital, Ängelholm, Sweden and one of the study authors.  “The one-year results from iMIA clearly show consistent outcomes with the previously published U.S. RCT, INSITE, thus further validating the applicability of the iFuse Implant to patients across a broad spectrum of clinical practitioners.”

Aaron Calodney, MD of Texas Spine & Joint Hospital in Tyler, TX said, “as a member and past president of the American Society of Interventional Pain Physicians, I am delighted to see such a high-quality study be published in the Pain Physician journal.  In addition, I continue to be impressed with both the quantity and quality of the clinical evidence being generated that clearly separates the iFuse Implant from all other SI joint surgical options.”

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain2-5, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.6 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint. 

SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections to confirm the diagnosis.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse Implant was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials. 

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with certain types of sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.  

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9760.092517

1.        Dengler J, Kools D, Pflugmacher R, et al. 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. 
           Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain. Pain Physician. 2017;20:537-50.
2.        Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res
           1987;217:266–80.
3.        Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
4.        Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in
           54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
5.        Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
6.        DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain 
           Med
. 2011;12:732–9.

 

 

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SOURCE SI-BONE, Inc.