Digital health company Omada Health presented encouraging research results on Tuesday suggesting its diabetes prevention platform — which virtually connects prediabetic patients with health coaches and clinicians — could help curb the symptoms of the disease as well as an equivalent program delivered in person.

The research is in some ways the biggest test yet of a digitally rendered diabetes treatment program ever performed. The study — a randomized controlled trial of nearly 600 people with prediabetes — is larger, longer, and more rigorous than previous studies of similar programs. Omada shared its findings in a presentation during ObesityWeek, a virtual medical conference organized by the Obesity Society; they have yet to be published in a scientific journal.

​Read More: ​https://www.statnews.com/2020/11/03/omada-health-prediabetes-predict-study/

SUNNYVALE, Calif., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the appointment of Kevin Ballinger to the company’s Board of Directors. Simultaneously, the company also announced the resignation of current board member, Ruoxi Chen. Both of these changes are effective immediately.

Ballinger, the recently appointed Chief Executive Officer of Aldevron, brings decades of experience in the medical device industry. Prior to joining Aldevron, he spent 25 years at Boston Scientific, a company focused on a variety of interventional medical specialties. During his last nine years at Boston Scientific, he served as Executive Vice President and Global President of the Interventional Cardiology division. Under his leadership, Ballinger grew the division to a $3 billion global business. Ballinger earned his BS in Mechanical Engineering from Michigan Technological University, and his MBA from the University of Minnesota’s Carlson School of Management.

​Read More: ​https://www.globenewswire.com/news-release/2020/12/03/2139512/0/en/Silk-Road-Medical-Announces-Changes-to-Board-of-Directors.html#:~:text=03%2C%202020%20(GLOBE%20NEWSWIRE),the%20company's%20Board%20of%20Directors.&text=Under%20his%20leadership%2C%20Ballinger%20grew,a%20%243%20billion%20global%20business.

SUNNYVALE, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today reported financial results for the three months ended September 30, 2020.
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“We had a strong third quarter in which our revenues grew 18% year over year. Our patient first culture and unwavering commitment to reduce stroke risk are evidenced by our recent milestone of 25,000 cumulative procedures,” said Erica Rogers, President and Chief Executive Officer of Silk Road Medical. “We are continuing to make meaningful investments in our team and our strategic priorities, paving the way for the bright future ahead of us.”

Read More: https://www.nasdaq.com/press-release/silk-road-medical-reports-third-quarter-2020-financial-results-2020-11-10

SUNNYVALE, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that it is strengthening its leadership team with two appointments. William Whealon, Ph.D. has joined the company as Executive Vice President of Research and Development, effective immediately. Silk Road Medical has also named Lucas Buchanan, the company’s current Chief Financial Officer, to also serve as its Chief Operating Officer, effective October 1, 2020.

“We are excited to welcome Bill to Silk Road Medical as we further strengthen our leadership team. His proven track record for building and leading effective and innovative R&D groups and his passion for identifying solutions to solve unmet clinical needs will be instrumental in our continued efforts to achieve durable growth,” said Erica Rogers, President and Chief Executive Officer of Silk Road Medical.

Read More: ​https://www.globenewswire.com/news-release/2020/09/21/2096802/0/en/Silk-Road-Medical-Strengthens-Leadership-Team.html

SUNNYVALE, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that positive results from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project comparing TCAR and carotid endarterectomy (CEA) have been published in Annals of Surgery1.

“These results continue to show low in-hospital stroke, death, and combined stroke/death rates as well as statistically lower rates of in-hospital cranial nerve injury and in-hospital myocardial infarction compared to CEA,” said Dr. Mahmoud Malas, Chief of Vascular and Endovascular surgery at UC San Diego Health. “These promising outcomes will likely increase the role of TCAR in the management of carotid artery stenosis.”

​Read More: https://www.globenewswire.com/news-release/2020/09/21/2096566/0/en/Compelling-Outcomes-with-TCAR-vs-CEA-in-Patients-with-Carotid-Artery-Stenosis-Published-in-the-Annals-of-Surgery.html

After raising $125 million for its commercialization efforts earlier this year, portable dialysis machine manufacturer Outset Medical is now going public with a $241.7 million Nasdaq IPO.

Trading under the ticker symbol "OM," the company priced 8.95 million of its shares at $27 apiece, upsizing its previous plans to offer 7.6 million shares between $22 and $24—a 38% boost overall, according to Renaissance Capital. The offering is set to close Sept. 17.

The former Fierce 15 winner’s Tablo hemodialysis system is designed to serve as a standalone unit. While traditional machines may require a connection to an outside source of clean water, the Tablo unit includes integrated water purification hardware, allowing it to run off of tap water and a basic electrical outlet.

Read More: https://www.fiercebiotech.com/medtech/portable-dialysis-device-maker-outset-medical-raises-242m-ipo​

Portable dialysis business Outset Medical Inc. filed plans on Monday to raise $100 million in an IPO.

The move comes months after the San Jose company raised $125 million to help move into new headquarters on Orchard Drive in San Jose and expand manufacturing of its Tablo Hemodialysis Systems in Morgan Hill.

Outset has raised more than $500 million and was valued at about about $725 million after a funding in February of this year, according to PitchBook Data.

Read More: https://www.bizjournals.com/sanjose/news/2020/08/24/outset-medical-files-plans-for-100m-ipo-san-jose.html

SUNNYVALE, Calif., July 09, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that Andrew Davis has been promoted to Chief Commercial Officer.

In this newly created role, Mr. Davis will oversee Silk Road Medical’s global commercialization efforts. Mr. Davis joined Silk Road Medical as the company’s first commercial leader in 2015 and has successfully built the sales team to over 100 customer facing field members, achieving over $125 million in cumulative revenue. As Chief Commercial Officer, Mr. Davis is an integral member of the executive team responsible for establishing near term priorities and setting the long-term strategic direction for the company. 

“Andy and his team have had a monumental role in our commercial success driving the safe adoption of TCAR across the U.S.,” said Erica Rogers, Chief Executive Officer. “His contributions to the development of our sales team and commercial strategy have been vital to our organization. In his new role, we are confident that Andy will provide additional strategic direction and value and deliver meaningful and lasting results for Silk Road Medical.”

Read More: ​https://www.globenewswire.com/news-release/2020/07/09/2060262/0/en/Silk-Road-Medical-Promotes-Andrew-Davis-to-Newly-Created-Position-of-Chief-Commercial-Officer.html#:~:text=(Nasdaq%3A%20SILK)%2C%20a,Road%20Medical's%20global%20commercialization%20efforts.

New Guidelines Consistent with Silk Road Medical Certification Process

SUNNYVALE, Calif., June 30, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the In-Press release of a clinical competence statement on training and credentialing for TransCarotid Artery Revascularization (TCAR), written by the SVS Writing Committee. The competence statement, published in the Journal of Vascular Surgery, provides recommendations on physician training and skills required to obtain and maintain clinical privileges to perform TCAR within an institution.

The statement outlines three credentialing pathways for physicians, providing multiple options to obtain the requisite endovascular and surgical skills. The physician training recommendations in the statement vary based on prior experience and, importantly, are consistent with the training program offered by Silk Road Medical. Recent data released in the Journal of the American College of Surgeons demonstrated the effectiveness of this curriculum with similar results in all major outcomes for TCAR among newly trained surgeons as well as their more experienced counterparts. The SVS guidance also cited evidence supporting the use of TCAR, including the low stroke and death rates observed in the PROOF and ROADSTER studies, as well as outcomes from the TCAR Surveillance Project, which demonstrate the broad applicability of TCAR in real world practice.

Read More: https://investors.silkroadmed.com/news-releases/news-release-details/society-vascular-surgery-svs-issues-guidance-competence

SUNNYVALE, Calif., May 20, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK) (“Silk Road Medical”), a company focused on reducing the risk of stroke and its devastating impact, today announced that in connection with its previously announced public offering of 6,808,154 shares of its common stock, the underwriters fully exercised and closed on their option to purchase up to an additional 1,021,223 shares of common stock from certain selling securityholders at the public offering price of $39.00 per share, less the underwriting discounts and commissions. Silk Road Medical did not receive proceeds from the sale of its common stock by the selling securityholders.
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J.P. Morgan and BofA Securities acted as joint book-running managers of the offering. Citigroup also acted as book-running manager. Stifel acted as co-manager.

Read More: https://www.globenewswire.com/news-release/2020/05/20/2036678/0/en/Silk-Road-Medical-Announces-Full-Exercise-and-Closing-of-Over-Allotment-Option.html