Silk Road Medical, which sells medical devices used in TCAR for the treatment of carotid artery disease, filed on Monday with the SEC to raise up to $86 million in an initial public offering. 

The Sunnyvale, CA-based company was founded in 2007 and booked $35 million in sales for the 12 months ended December 31, 2018. It plans to list on the Nasdaq under the symbol SILK. Silk Road Medical filed confidentially on December 19, 2018. J.P. Morgan and BofA Merrill Lynch are the joint bookrunners on the deal. No pricing terms were disclosed.

The article TCAR device maker Silk Road Medical files for a $86 million IPO originally appeared on IPO investment manager Renaissance Capital's web site renaissancecapital.com. ​

Read More: https://www.nasdaq.com/article/tcar-device-maker-silk-road-medical-files-for-a-86-million-ipo-cm1108850

​LEXINGTON, Mass., Feb. 27, 2019 /PRNewswire/ -- Tepha Inc. announced today the initiation of a pilot clinical evaluation of the Company's P4HB regenerative polymer scaffold for the surgical treatment of stress urinary incontinence (SUI).  The study was initiated in Cape Town, South Africa in partnership with the Pelvic Floor Foundation of South Africa ("PFFSA") and the University of Cape Town.  The first procedures were performed by co-principal investigators, Dr. Stephen Jefferyof the University of Cape Town and Professor Jan-Paul Roovers of the Academic Medical Center, Amsterdam, The Netherlands.  The Cape Town SUI study represents the first clinical application of Tepha's P4HB polymer technology in the field of urogynecology.  Based in Lexington, MA, Tepha is the pioneer developer and exclusive supplier of the P4HB polymer for medical applications that include hernia repair, plastic surgery, tendon & ligament repair, and wound closure.

Read More: ​https://www.prnewswire.com/news-releases/tepha-inc-announces-initiation-of-clinical-evaluation-of-p4hb-regenerative-scaffold-for-stress-urinary-incontinence-300803224.html

After winding down its consumer-oriented operations last July, mental health startup Lantern has partnered with larger mental health providers to license its IP. In addition to licensing its IP to Omada Health, Lantern has licensed its tech to Spring Health, Ginger and two others. 

Spring Health, which offers mental health benefits for large employers, provides personalized, clinically proven approaches to mental health care for employees. But Spring Health has always wanted to integrate digital cognitive behavioral therapy into its approach, Spring Health CEO April Koh told TechCrunch.

Spring Health has already offered psychiatry, therapy and self-help tools, but it was wanting to refer people to digital CBT, Koh said.

“There was really only one player that was committed to evidence as deeply as we were and that was Lantern,” she said. “So when the opportunity presented itself, we were thrilled.”

Read More: ​https://techcrunch.com/2019/02/12/mental-health-startup-lantern-will-continue-to-live-through-ip-licensing-deals/

​Embolic protection, new stents, and TCAR are narrowing the gap between CAS and CEA, but medical therapy could still hold its own in CREST-2.

​HOLLYWOOD, FL—Carotid artery stenting (CAS) and endarterectomy (CEA) remain neck and neck in vying for prominence, but some experts say a minimally invasive surgical approach known as transcarotid artery revascularization (TCAR), as well as new filters and devices that aim to cut the risk of minor stroke with stenting, could well shift the balance away from surgery.

Moreover, still-pending results from the CREST-2 trial will clarify the position of medical therapy compared with revascularization.

“We were running a little bit behind milestones, and I think right now we’re about right at milestones in terms of achieving the actual enrollment,” Barry T. Katzen, MD (Miami Cardiac & Vascular Institute, FL), reported at the 2019 International Symposium on Endovascular Therapy (ISET). “So this trial is moving along quite well, just slightly below the projected accrual rate. Interestingly enough, endarterectomy was lagging behind stenting in terms of accrual, but now it’s pretty much 50-50, which is great news for the ultimate statistical analysis of this trial.”

Read More: https://www.tctmd.com/news/surmounting-minor-stroke-new-devices-tcar-aim-cut-risk-carotid-artery-stenting

Dr. Michael Aragon and Stacey Porter Bring Wealth of Clinical and Organizational Expertise During Time of Company Grow

SAN JOSE, Calif.--(BUSINESS WIRE)--Outset Medical, a commercial-stage company delivering first-of-its-kind technology into the growing global dialysis market, today announced the appointment of two new executives: Michael Aragon, M.D., who joins as Chief Medical Officer, and Stacey Porter, as Vice President, People Operations.

Dr. Aragon is an accomplished board-certified internist and nephrologist who previously spent 14 years in clinical practice and as a medical director for DaVita and U.S. Renal Care, caring for end-stage renal disease patients in dialysis clinics, hospitals, and homes. Dr. Aragon was also the founding partner and president of North Texas Kidney Consultants and served as the medical director of acute hospital dialysis programs with Texas Health Resources Harris Fort Worth, a 660-bed hospital providing more than 700 dialysis treatments per month. He is currently Chairman of the Board of Directors for the End-Stage Renal Disease (ESRD) Network of Texas. Dr. Aragon received his training at the University of Texas Health Sciences Center in Houston after completing his undergraduate degree at Texas ​A&M University.

Read More: https://www.businesswire.com/news/home/20190115005275/en/Outset-Medical-Appoints-Chief-Medical-Officer-People

When Sean Duffy, the cofounder and CEO of a digital-health startup called Omada Health, took his first look at the results of his new diabetes-treatment program, he noticed a disturbing trend.

Many of the individuals weren't simply fighting diabetes or obesity. They were also battling psychological issues like depression and anxiety, and those conditions were making their obesity-related symptoms worse.

Duffy wondered if there was more Omada could do to help treat those psychological issues.

So roughly a year ago, he and his team began drafting plans for a program that would focus exclusively on depression and anxiety, while also giving existing customers access to a wider range of mental-health tools. Duffy officially announced the program, which includes a partnership with a mental-health startup called Lantern, on Monday.
​
Read More: ​https://www.businessinsider.com/silicon-valley-diabetes-startup-omada-now-tackling-depression-lantern-2019-1

BOSTON, Jan. 8, 2019 /PRNewswire/ -- Blue Cross Blue Shield of Massachusetts (Blue Cross) recently added two new digital health solutions to its Emerging Solutions portfolio—Robin Care for cancer support and Hinge Health for musculoskeletal conditions such as back and knee pain.

The company introduced Emerging Solutions earlier this year to find innovative digital solutions and advise employer customers on options to help improve their employees' health and lower costs. Blue Cross launched the portfolio with solutions for diabetes management (Livongo and Omada) and fertility, pregnancy and parenting (Ovia Health).

According to the National Business Group on Health 2019 Large Employer Health Care Strategy & Plan Design Survey, more than 50% of large employers plan to implement more virtual care solutions as their top initiative in 2019, with specific interest in behavioral health, lifestyle coaching, musculoskeletal conditions, diabetes management and physical therapy. 

Read More: https://www.prnewswire.com/news-releases/blue-cross-blue-shield-of-massachusetts-adds-two-new-digital-health-solutions-for-large-self-insured-clients-300774917.html

Transcarotid artery revascularization with a neuroprotection system was associated with a low rate of stroke in patients with carotid artery stenosis, according to 1-year results of the ROADSTER trial.

As Cardiology Today’s Intervention previously reported, transcarotid artery revascularization (TCAR) with a neuroprotection system (Enroute, Silk Road Medical) was associated with lower 30-day stroke and death rates compared with traditional carotid stenting

For the present analysis, researchers analyzed 165 patients (112 from pivotal phase; 53 from extended-access cohort; mean age, 74 years; 65% men; 80% asymptomatic) with carotid artery stenosis at high risk for endarterectomy.

According to the researchers, high-risk anatomic factors included 11% of patients with contralateral carotid artery occlusion, 1.8% with tandem stenosis greater than 70%, 25% with high cervical carotid artery stenosis, 25.6% with restenosis after carotid endarterectomy, 4.3% with bilateral stenosis requiring treatment and 14.6% with a hostile neck. In addition, some patients had high-risk cardiac factors, including 14% with coronary disease in two or more vessels and a history of angina.

Read More: ​https://www.healio.com/cardiac-vascular-intervention/cerebrovascular/news/online/%7bf2df72f5-1e66-4685-bf00-5eb0939230d4%7d/novel-transcarotid-device-yields-low-stroke-rate-during-carotid-artery-stenting

​Phase 1a Dose-Escalation Data Demonstrates a Favorable Safety Profile and Signals of Immune Cell Modulation in Patients with Late Stage Solid Tumors

REDWOOD CITY, Calif. and WASHINGTON, Nov. 09, 2018 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, today announced initial results from the Phase 1a dose escalation portion of a Phase 1a/b trial of etigilimab, the company’s anti-TIGIT antibody. TIGIT (T-cell immunoreceptor with Ig and ITIM domains) is a next generation checkpoint receptor shown to block T-cell activation and the body’s natural anti-cancer immune response. OncoMed’s anti-TIGIT checkpoint inhibitor candidate is an IgG1 monoclonal antibody which binds to the human TIGIT receptor on T-cells with a goal of improving the activation and effectiveness of T-cell and NK cell tumor-killing activity. The data were presented today at the Society for Immunotherapy of Cancer meeting taking place in Washington, D.C.

Read More: ​​https://globenewswire.com/news-release/2018/11/09/1648928/0/en/OncoMed-Announces-Early-Clinical-Data-for-anti-TIGIT-Antibody.html

Overall Clinical Benefit Rate of 85%, Partial Response Rate of 42% and Progression Free Survival of 5.4 Months Observed in Patients with > 2 Prior Therapies and/or Prior Bevacizumab

REDWOOD CITY, Calif., Oct. 20, 2018 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, today announced interim results from its ongoing Phase 1b trial investigating navicixizumab, OncoMed's anti-DLL4/VEGF bispecific antibody, in combination with paclitaxel in patients with platinum-resistant ovarian cancer.

The interim results were presented at the European Society for Medical Oncology in Munich. The patients had received a median of four prior therapies, all of whom had received prior paclitaxel and 69% had received prior bevacizumab. Twentytwo of the 26 patients (85%) treated with the novel regimen experienced clinical benefit. Notably 11 of the 26 patients (42%) achieved a partial response and the median progression-free survival was 5.4 months (95% CI: 3.5-8.0 months). Historical response rates for patients with heavily pretreated platinum-resistant ovarian cancer treated with chemotherapy are typically 15% or less.

Read More: https://oncomed.gcs-web.com/static-files/ce0dd21c-2466-40d8-85de-2c79d7c0f87d