Mainstay Medical launches implantable neurostim system in U.S.

Mainstay Medical today announced the limited commercial launch of its ReActiv8 implantable restorative neurostimulation system in the U.S.

The Ireland-based company designed ReActiv8 to treat intractable chronic lower back pain. The system will be available in the U.S. through ReActiv8-certified physicians this summer.

“We are delighted to commercially launch ReActiv8 in the U.S. and make this innovative Restorative Neurostimulation therapy available to Americans suffering from intractable chronic low back pain. Supported by more than 10 years of clinical research, ReActiv8 is the only proven neurostimulation system to address mechanical intractable low back pain. Physicians will finally have access to a therapy to treat these patients beyond temporary treatments designed to merely mask the pain for a limited time,” CEO Jason Hannon said in a news release. “We are launching in a limited fashion to ensure we provide proper education to physicians and assist them…

Read more
  • 0

MedTech 100 roundup: Slight dip after all-time best for industry

The medtech industry’s stocks rose higher than they ever had to begin last week before eventually dropping to a slightly more normal level.

MassDevice‘s MedTech 100 index ended the week (Feb. 19) at 108.72 points, marking a -1.7% dip from the 110.63-point mark set at the end of the previous week (Feb. 12). On Monday (Feb. 15) the index hit its highest mark ever, though, rising to 110.96 points.

That mark sets an all-time best for the index, which has been on the rise for practically all of 2021 so far. It previously reached 106.81 points on Jan. 8, then 107.4 points on Jan. 20 before besting itself again with last week’s finish. The improvement has been considerably impressive given that the index had never reached even the 100-point mark before November 2020.

Medtech’s latest tally means the index has risen 17.8% from the pre-COVID-19 pandemic high of 92.32, set on Feb. 19, 2020. Additionally, the industry has very much rebounded from its lowest p…

Read more
  • 0

DTW Podcast – Tale of Two CEOs – How Tim Herbert led Inspire to an IPO; Where Rob Bodor wants to take Protolabs

Inspire Medical CEO Tim Herbert never set out to be a CEO. Yet, he spun of a promising sleep apnea technology out of Medtronic and assembled a team that not only went public, but helps hard-to-treat apnea patients live healthier lives through better sleep.

Oh, and the electrical engineer turned startup-CEO took the medtech public in 2018. Listen to this episode to hear how Inspire management worked with the FDA, payers and public investor to build a burgeoning neuromed giant.

Co-host Tom Salemi also talks to Rob Bodor, the incoming CEO at Protolabs. Bodor succeeds the highly successful Vicki Holt who built the manufacturing company into an acquisitive powerhouse. Hodor shares what’s next for the company.

Co-cost Chris Newmarker, executive editor of life sciences at MassDevice, unveils this week’s Newmarker’s Newsmakers featuring news from Thermo Fisher Scientific, Mainstay Medical, Theranos, Butterfly Networks and Zimmer Biomet’s …

Read more
  • 0

Mainstay Medical raises $108M

Dublin, Ireland-based Mainstay said in a news release that it plans to use the funds for the commercial launch of the ReActiv8 system in the U.S., along with continued expansion in Europe and Australia, plus post-market clinical studies and research.

ReActiv8 is a neurostimulation device designed to treat intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy and are not candidates for spine surgery. Mainstay received FDA premarket approval for the device in June 2020.

Ally Bridge Group and Sofinnova Partners, the former being a new investor, co-led the financing, while an unnamed large global medical device company also participated. KCK Group and Fountain Healthcare Partners also participated.

“A financing of this magnitude, supported by such a quality global investor group, is testament to the confidence in the commercial opportunity for ReActi…

Read more
  • 0

FDA approves Mainstay Medical neurostim device

Mainstay Medical announced that it received FDA premarket approval for its ReActiv8 implantable neurostimulation system for chronic low back pain.

ReActiv8 treats intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy and are not candidates for spine surgery, according to a news release.

Mainstay said ReActiv8 garnered PMA after a 204-patient, international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way crossover that was conducted under FDA investigational device exemption.

The company said it is now refining its U.S. commercial launch plans for ReActiv8, including the build-out of its commercial team, inventory procurement and related matters, along with evaluating the needed financial resources.

“We are thrilled to receive FDA approval of ReActiv8, which is designed to be a restorative treatmen…

Read more
  • 0