Axonics Modulation Technologies Inc. (Nasdaq: AXNX) is getting closer to Food and Drug Administration clearance for the company’s first big product, the implantable r-SNM System, which uses mild electrical pulses as a treatment for people with urinary and fecal dysfunction.
On Feb. 19, Axonics shares increased 9.5% to $18 after it announced positive topline results from its r-SNM study.
“The clinical study demonstrated that patients implanted with the Axonics r-SNM System received clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life,” said a company statement.
“Additionally, the study met all secondary endpoints. No serious device-related adverse events have been reported.”
Axonics said it is close to filing six-month clinical data with the FDA.
The Irvine-based device maker in December filed a premarket approval application and interim clinical data from the study. The company doesn’t expect the additional clinical data will affect the standard 180-day premarket approval timeline.
The company, which went public on Oct. 31 at $15 a share, had about a $500 million market cap as of press time.
The r-SNM System is already approved for head and neck MRI scans in Europe, Canada and Australia. European CE Mark approval of full-body MRI conditional labeling is currently pending.
Urology Care Foundation estimates that about 33 million Americans have overactive bladder, a sudden, uncontrollable urge to urinate, with as many as 30% of men and 40% of women. Current treatments include pelvic floor muscle exercises, medications, as well as absorbent pads and diapers.
Heart Health
Irvine-based Biosense Webster Inc. earlier this month launched an FDA investigational device exemption study of its Qdot Micro radiofrequency ablation catheter to treat irregular heartbeats.
The FDA exemption permits the not-yet-approved device to be used in a patient study to collect safety and effectiveness data.
Qdot Micro RF catheter is the first of its kind to deliver 90 watts of radio frequency power in a short, four-second session, according to the company. It said “ordinary ablation systems use power levels on average of between 20 to 40 watts and durations of 20 to 40 seconds.”
Biosense Worldwide President Uri Yaron said in a statement the company believes this ablation catheter will revolutionize the field.
The first patient in the trial was treated at NYU Langone Health.
The study plans to enroll a total of 185 patients in the U.S. at 30 centers.
The device maker, a unit of Johnson & Johnson, develops products used in diagnosis and treatment of cardiac arrhythmias. Atrial fibrillation is the most common arrhythmias.
Wound Healing
A UCI scientist was part of a research team that discovered a method to manipulate wound healing that leads to skin regeneration rather than scarring.
Maksim Plikus, an associate professor at University of California-Irvine School of Biological Sciences, George Cotsarelis from University of Pennsylvania and colleagues wrote in the research journal “Nature Communications,” that the body’s own blood cells could help with scar-free wound healing.
The job of a scar is to close a wound as quickly as possible, even if the wound is from a planned surgery. Excessive scarring is not good and can lead to complications like irritation, inflammation and adhesions between organs.
“The secret is to regenerate hair follicles first. After that, the fat will regenerate in response to the signals from those follicles,” said Cotsarelis, who was the principal investigator on the project.
Autism Center
Easterseals Southern California on Jan. 31 opened its autism therapy and disability services center at 1063 McGaw Ave. in Irvine.
It’s also the nonprofit’s corporate office after expanding its former Santa Ana headquarters last year. The David and Molly Pyott Foundation provided a $1.72 million gift in support of that development.
The donation from the Pyotts—Molly is ESSC board chair and David, philanthropist and former Allergan chief executive—will be used to pay off the Santa Ana location’s mortgage and renovate the site to create its new adult day services.
The ESSC Adult Day Services Center is scheduled to open mid-year.
The nonprofit serves 10,000 people with developmental disabilities throughout Southern California.
