Medtech Leaders’ Post

🚽 Neuspera Medical Inc. Medical raises $23m to advance implantable SNM system Other participants in the financing round include Action Potential Venture Capital, Windham Venture Partners, Olympus Innovation Ventures, and another strategic investor. Neuspera is developing the Neuspera Implantable Sacral Neuromodulation (SNM) System for treating urinary urge incontinence (UUI), a symptom of overactive bladder (OAB). The funding will support Neuspera’s efforts to obtain the US Food and Drug Administration (FDA) premarket approval (PMA) for the Neuspera system. Read more online: https://lnkd.in/gRTZygNF 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

The FDA recently granted authorization to LumiThera, Inc., allowing the company to market its Valeda Light Delivery System. This approval, made under the De Novo authorization pathway, makes Valeda the first FDA-authorized device to treat vision loss in patients with dry AMD. I had the opportunity to speak with LumiThera President and CEO Clark Tedford to learn more about the Valeda technology, its role in the dry AMD market, and the company’s commercialization plans. https://lnkd.in/g28Q9Wxy Eyewire+

Orthocell Ltd (ASX:OCC, OTC:ORHHF) is gearing up to launch proprietary #NerveRepair medical device #Remplir to the US$1.6 billion US market, after securing A$17 million in a share placement involving up to 28.3 million shares. The company welcomed a notable number of new leading Australian and international institutional investors under this latest placement, alongside key existing institutional shareholders and life science funds. OCC expects the capital raise will fully fund the launch of Remplir into the US market – the company is currently on-track to release top-line results from its US authorisation study and submit its US 510(K) market authorisation application in the fourth quarter of this calendar year. “We are extremely pleased to announce this significant placement following on from our second consecutive quarter of record revenue, regulatory approval of Remplir in Singapore, successful first sales of Striate in Canada, and the exciting outlook for the company as it progresses approvals in new key jurisdictions like the US," Orthocell chair John Van Der Wielen said. More at #Proactive #ProactiveInvestors #OCC #ASX #Biotech #MedicalDevices #RegenerativeMedicine http://ow.ly/ys1M105MUY1

Shareables: ViroMed Medical AG Plans to Acquire All Shares of ActivCell Group AG by Way of a Capital Increase Against Contribution in Kind with Exclusion of Subscription Rights Business Wire India Viromed Medical AG (Ticker: VMED; ISIN: DE000A3MQR65; “Viromed”; the “Company”) plans to acquire all shares in ActivCell Group AG, Switzerland, and thus strategically expand its product portfolio. To this end, the Company has today signed a term sheet with the owners of ActivCell Group AG and will immediately enter into further negotiations with the objective of concluding an agreement. With the acquisition of ActivCell Group AG, Viromed expands the treatment spectrum of its products with additional indications and expects an accelerated market launch in the European Union with its own cold plasma product series.   ActivCell Group […] - https://lnkd.in/gkefzt_h 𝗖𝗹𝗶𝗰𝗸 𝘁𝗼 𝗝𝗼𝗶𝗻 𝘁𝗵𝗲 𝗙𝗮𝘀𝘁𝗲𝘀𝘁 𝗚𝗿𝗼𝘄𝗶𝗻𝗴 𝗡𝗲𝘁𝘄𝗼𝗿𝗸 - https://lnkd.in/gsYmD_BZ #IndianConventions #TaleesRizvi #News #Awards #Conferences #India #HR #Marketing #Finance #StartUp #Business #B2B #B2C #C2C #D2C #leadership #Management #HumanResources #Healthcare

🟥 Diabetes News 🟥 Beta Bionics announced yesterday that it has filed a registration statement with the SEC for a proposed initial public offering (IPO). The specific number of shares to be offered and the price range have not yet been determined. Based in Irvine, California, Beta Bionics plans to list its common stock on the Nasdaq under the ticker symbol “BBNX.” The proposed offering is being led by BofA Securities, Piper Sandler, and Leerink Partners, with Stifel acting as a bookrunner and Lake Street Capital Markets serving as co-manager. Taking the company public would represent a significant milestone in Beta Bionics’ recent history and could signal a resurgence in IPO activity within the medical device industry. Other medtech companies, such as Medline Industries, LP, Anteris Technologies (focused on transcatheter heart valves), and neurotech firm CeriBell, have also announced IPO plans recently. Beta Bionics is the developer of the #iLet #bionicpancreas, an FDA-cleared automated #insulin delivery system that simplifies #diabetes management for patients and physicians. Approved in May 2023, the #iLet system eliminates the need for carb counting or #insulin correction calculations, relying instead on the user’s weight as the sole input. It autonomously calculates and administers all insulin doses throughout the day, allowing users to "go bionic." The company has achieved several major milestones in recent years. In November 2024, Beta Bionics raised $60 million in a Series E funding round, following a $100 million Series D round in August 2023. By August 2024, the #iLet system had surpassed 10,000 patient starts. Furthermore, in October 2024, Beta Bionics announced the integration of its #iLet system with Abbott’s #FreeStyleLibre3 Plus continuous glucose monitoring technology. Image from Beta Bionic

ViroMed Medical AG Plans to Acquire All Shares of ActivCell Group AG by Way of a Capital Increase Against Contribution in Kind with Exclusion of Subscription Rights Viromed Medical AG (Ticker: VMED; ISIN: DE000A3MQR65; “Viromed”; the “Company”) plans to acquire all shares in ActivCell Group AG, Switzerland, and thus strategically expand its product portfolio. To this end, the Company has today signed a term sheet with the owners of ActivCell Group AG and will immediately enter into further negotiations with the objective of concluding an agreement. With the acquisition of ActivCell Group AG, Viromed expands the treatment spectrum of its products with additional indications and expects an accelerated market launch in the European Union with its own cold plasma product series.   ActivCell Group […] - https://lnkd.in/gs4wuziZ 𝗖𝗹𝗶𝗰𝗸 𝘁𝗼 𝗝𝗼𝗶𝗻 𝘁𝗵𝗲 𝗙𝗮𝘀𝘁𝗲𝘀𝘁 𝗚𝗿𝗼𝘄𝗶𝗻𝗴 𝗡𝗲𝘁𝘄𝗼𝗿𝗸 - https://lnkd.in/gsYmD_BZ #IndianConventions #TaleesRizvi #News #Awards #Conferences #India #HR #Marketing #Finance #StartUp #Business #B2B #B2C #C2C #D2C #leadership #Management #HumanResources #Healthcare

Shareables: ViroMed Medical AG Plans to Acquire All Shares of ActivCell Group AG by Way of a Capital Increase Against Contribution in Kind with Exclusion of Subscription Rights Viromed Medical AG (Ticker: VMED; ISIN: DE000A3MQR65; “Viromed”; the “Company”) plans to acquire all shares in ActivCell Group AG, Switzerland, and thus strategically expand its product portfolio. To this end, the Company has today signed a term sheet with the owners of ActivCell Group AG and will immediately enter into further negotiations with the objective of concluding an agreement. With the acquisition of ActivCell Group AG, Viromed expands the treatment spectrum of its products with additional indications and expects an accelerated market launch in the European Union with its own cold plasma product series.   ActivCell Group […] - https://lnkd.in/gBKMCK-c 𝗖𝗹𝗶𝗰𝗸 𝘁𝗼 𝗝𝗼𝗶𝗻 𝘁𝗵𝗲 𝗙𝗮𝘀𝘁𝗲𝘀𝘁 𝗚𝗿𝗼𝘄𝗶𝗻𝗴 𝗡𝗲𝘁𝘄𝗼𝗿𝗸 - https://lnkd.in/gsYmD_BZ #IndianConventions #TaleesRizvi #News #Awards #Conferences #India #HR #Marketing #Finance #StartUp #Business #B2B #B2C #C2C #D2C #leadership #Management #HumanResources #Healthcare

Microbot Medical has submitted a 510(k) premarket notification for its disposable endovascular robotic system, LIBERTY, to the US Food and Drug Administration (FDA) seeking approval for commercial launch. Microbot Medical chairman, CEO and president Harel Gadot said: “This is a pivotal milestone for our company, as the 510(k) submission reflects the commencement of our transition to a commercially focused company" Click here for the full article - https://lnkd.in/deAz8qPt #medicaldevice #medtech #medicalrobotics #surgicalrobotics

LENSAR Reports Second Quarter 2024 Results and Provides Business Update August 08, 2024 17 New ALLY ® Adaptive Cataract Treatment Systems placed in 2Q 2024; highest number of placements since launch Received Medical Device Regulation (MDR) certification (CE Mark) and Taiwan FDA approval granted for commercial distribution of ALLY; First EU and Southeast Asia systems shipped Continued robust worldwide procedure growth; 2Q 2024 procedure volumes increased 19% over 2Q 2023 Installed system base grew 16% over 2Q 2023 ORLANDO, Fla.--(BUSINESS WIRE)-- LENSAR ® , Inc. (Nasdaq: LNSR) (“LENSAR” or “the Company”), a global medical technology company focused on advanced laser solutions for the treatment of cataracts, today announced financial results for the quarter ended June 30, 2024 and provided an update on key operational initiatives. https://lnkd.in/ednHtF37

ViroMed Medical AG Plans to Acquire All Shares of ActivCell Group AG by Way of a Capital Increase Against Contribution in Kind with Exclusion of Subscription Rights Viromed Medical AG (Ticker: VMED; ISIN: DE000A3MQR65; “Viromed”; the “Company”) plans to acquire all shares in ActivCell Group AG, Switzerland, and thus strategically expand its product portfolio. To this end, the Company has today signed a term sheet with the owners of ActivCell Group AG and will immediately enter into further negotiations with the objective of concluding an agreement. With the acquisition of ActivCell Group AG, Viromed expands the treatment spectrum of its products with additional indications and expects an accelerated market launch in the European Union with its own cold plasma product series.   ActivCell Group […] - https://lnkd.in/gs4wuziZ 𝗖𝗹𝗶𝗰𝗸 𝘁𝗼 𝗝𝗼𝗶𝗻 𝘁𝗵𝗲 𝗙𝗮𝘀𝘁𝗲𝘀𝘁 𝗚𝗿𝗼𝘄𝗶𝗻𝗴 𝗡𝗲𝘁𝘄𝗼𝗿𝗸 - https://lnkd.in/gsYmD_BZ #IndianConventions #TaleesRizvi #News #Awards #Conferences #India #HR #Marketing #Finance #StartUp #Business #B2B #B2C #C2C #D2C #leadership #Management #HumanResources #Healthcare