BioHealth Innovation Weekly for January 3, 2023

In this episode of BioTalk with Rich Bendis, we’re joined by three guests from Solaxa: CEO & Founder Christian Walker, Chief Operating Officer Luis T. Gutierrez, Jr., and Chief Commercial Officer Jennifer Butler. Solaxa is a pioneering biotech company with a mission to revolutionize the treatment of cerebellar ataxias and acute nerve injuries caused by trauma and chemotherapy.

Discover the compelling story behind Solaxa’s choice to establish its roots in Montgomery County and how the BioHealth Capital Region has played a crucial role in its growth. Learn how Solaxa’s team was assembled, including the inspiring success stories of Luis and Jennifer, both part of the BioHealth Innovation and Montgomery County Maryland’s Executive in Residence program.

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The year “gaslighting” of women with hard-to-diagnose maladies was finally given the kabosh?
The year we found the hormone causing acute morning sickness?
Impressive and large funding rounds despite a bleak funding environment?
“Birth control for men” makes it to the clinical trial stage?

By Anna Zornosa - In the shadow of one very bad, no-good horrible development setting women’s health back decades (the overturning of Roe V. Wade), I spent the year taking note of some amazing advances happening in the pursuit of health solutions for women. Curious if others were also seeing bright spots, I asked some of the smartest women I know if they’d also seen events signaling notable progress.

My timing was bad: with the holidays upon us I knew some could not answer. But to my delight I got observations Barbara Levy, MD, FACOG, FACS : from CEO/Founders Somer Baburek, MBA (Hera Biotech), Melody Roberts (Liv Labs), and Melissa Bowley (Flourish Care); from author Susan Salenger; medtech designer and diversity driver Nada (Osman) Hanafi ; investors Jessica Karr and Susan Solinsky; and Ayse McCracken, Founder of the Ignite Accelerator for women leading life science companies.

What did we miss? A lot, certainly. Please add your own “brightspots of note” to comments. This will create something we can all turn to if (when) bad developments happen in 2024.

FDA IDE approval of Sonavex's randomized trial comes months after meeting the endpoint of its first clinical study

BALTIMORE, Jan. 2, 2024 /PRNewswire-PRWeb/ -- Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced that it completed its initial clinical study evaluating the ability to use EchoMark & EchoSure to improve the assessment of arteriovenous (AV) fistula maturation for dialysis patients. Following the positive findings from this study, Sonavex was granted approval from the U.S. Food and Drug Administration under an Investigational Device Exemption (IDE) for its randomized controlled trial, MAFASA (Maturation of Arteriovenous Fistula with Automated Sonography Assessments).

Sue Carr clearly remembers the moment that pushed her to become a full-time entrepreneur.

In 2018, Carr was working at a hospital in Montgomery County and responding to a critical situation in the emergency room. She had to administer life-saving medication that was packaged in a glass ampoule — a small glass vial with a bottle head — to a patient.

To open the ampoule, the bottle head must be broken off, which Carr said results in glass shards getting in medication.