Vertos Medical Inc. is looking to better quantify the improvements that are seen when patients with lower back problems use its products.
The Aliso Viejo-based medical device company, formed in 2005, develops minimally invasive treatments for lumbar spinal stenosis (LSS), the narrowing of the spinal canal.
Patients suffering from spinal decompression issues experience pain, weakness or numbness in their legs and lower backs, which limits their ability to stand and walk. The degenerative condition typically affects people 60 and older.
The typical lumbar spine surgery removes a layer of the vertebrate to create more space for the nerves. Vertos’ product works the same way, but does it less invasively via removing “the cause of the stenosis through a portal of the size of a baby aspirin,” the company said in a statement.
The company notes that its technology “requires no implants, no general anesthesia, no stiches and no overnight hospital stay.” The procedure received Food and Drug Administration clearance in 2006.
Nonsurgical treatments for LSS include medications, posture management, stretching and exercise.
The Vertos procedure has been performed on more than 20,000 patients and analyzed in more than 13 clinical studies, according to the company, which in mid-2017 raised $28 million in funding.
The latest study, announced this month, aims to add more quality-of-life data that result from the procedure.
The “randomized controlled study will use clinically validated, patient-reported outcome measures to identify improvements in pain and function, and will capture objective measures of participants’ activity levels using Fitbit activity trackers,” the company said in a statement.
The two-year study will enroll patients aged 50 to 80, and “will provide important data to help physicians and patients make early treatment decisions for LSS sufferers,” it said.
The first patient for the study was enrolled at Michigan Interventional Pain Center in Brownstown, Mich.
Chief Executive Eric Wichems said the new study “will provide powerful real-world, quality of life data.”
Investors in the company include MVM Life Science Partners LLP, Leerink Revelation Partners, Pitango Venture Capital, ONSET Ventures and Aweida Venture Partners.
People
• Hancock Jaffe Laboratories Inc. (Nasdaq: HJLI) refreshed its board this month with the addition of three independent directors: Drs. Francis Duhay and Sanjay Shrivastava, and Marc Robins.
The Irvine-based company makes bioprosthetic devices used to treat patients with cardiovascular diseases. It went public this year, raising $7.5 million in an initial public offering.
Duhay, a trained cardiac and thoracic surgeon, served as chief medical officer of Irvine-based heart valve maker Edwards Lifesciences Corp. (NYSE: EW) from 2012 to 2016. He led medical and clinical affairs for transcatheter and surgical heart valves at Edwards, which is Orange County’s largest public company, with a market value of about $30 billion.
Shrivastava, an 18-year medical device veteran who has chief executive experience at several medical device startup companies, was director of global marketing of Medtronic PLC’s cardiac and vascular group until June of last year.
Robins is currently the fund manager at Crown Capital Management LP, a new micro-cap and small-cap fund he started in July.
The additions bring Hancock Jaffe’s board up to five members, including Chairman Yury Zhvillo and Chief Executive Robert Berman.
They replaced board members who resigned at the start of the month; reasons for their departures were not disclosed.
Hancock Jaffe has three clinical-stage product candidates, including CoreoGraftO, which is intended to be used for coronary artery surgery for pediatric patients.
It has about a $35.8 million market cap.
• Ophthalmic drug maker Allegro Ophthalmics LLC promoted Vicken Karageozian to the president and chief executive roles at the San Juan Capistrano-based company. He was previously chief medical officer.
He succeeded his father, co-founder Hampar Karageozian, who was named executive chairman.
Versant Ventures Management LLC’s Bill Link, who joined the company’s board two years ago, said Vicken’s “clinical development expertise and experience working with private and institutional investors will position Allegro for future success.”
The new chief executive will prepare the company for the next key milestone, starting third-phase clinical trials of lead drug candidate Luminate in patients with diabetic macular edema.
Allegro is also studying the drug’s use in dry age-related macular degeneration. It raised $10.7 million in funding in 2017.
