L2Mtech | February 17, 2021
CE Mark Approval for LimusTrack™, Sirolimus Eluting Coronary Stent System for Cardiovascular Applications.
CE Mark Approval for LomiFlow™, Paclitaxel Drug Eluting Balloon for Cardiovascular Applications
CE Mark Approval for PearlFlow™, Paclitaxel Drug Elutin Balloon for Endovascular Applications
CE Mark Approval for PearlFlow NS™, Self Expandable Nitinol Stent System for Endovascular Applications
CE Mark Approval for FlexiTrack 018™, Peripheral Balloon Catheter for Endovascular Applications
CE Mark Approval for FlexiTrack 035™, Peripheral Balloon Catheter for Endovascular Applications
Bonn, Germany – L2Mtech GmbH has announced the award of its first CE Mark approval on Six (6) products:
LimusTrack™ : Sirolimus Coated Cobalt Chromium Stent with biodegradable polymer for the treatment of coronary artery disease, de novo lesions, restenosis lesions.
LomiFlow™ : Paclitaxel Coated balloon catheter for the treatment of coronary artery disease, small vessels, dilatation of de novo lesions, in-stent restenosis (ISR) cases.
PearlFlow™ : Paclitaxel Coated balloon catheter for the treatment of peripheral arterial disease, PTA, dilatation of stenotic segments or lesions in peripheral arteries.
PearlFlow NS™ : Self-Expanding Nitinol Stent System for the treatment of peripheral arterial disease, de novo lesions, lesions in femoropopliteal arteries.
FlexiTrack 018™ : Peripheral Balloon Dilatation catheter for the treatment of peripheral arterial disease, dilatation of lesions in femoral, popliteal, tibial arteries.
FlexiTrack 035™ : Peripheral Balloon Dilatation catheter for the treatment of peripheral arterial disease, dilatation of lesions in the SFA, femoral arteries.
L2Mtech GmbH Founder and CEO Lalit Mamtani said ‘‘We are very excited to have been awarded our first CE Mark on six products, CE Mark approval represents a key milestone for L2Mtech GmbH and is a testament to the efficacy and safety of our innovative technology products for Cardiovascular and Endovascular applications.“
We now prepare to commercially launch the products in all markets where the CE Mark is recognized. With introduction of our innovative technology products in markets, we will be able to expand treatment options for the benefit of many millions of patients with coronary and peripheral artery disease around the world.
Founded in 2017, L2Mtech GmbH is a privately-owned multinational medical device company headquartered at Bonn, Germany. L2Mtech specializes in design, development, manufacture and commercialization of medical devices that are used by healthcare establishments globally. L2MTech will provide interventional physicians with innovative vascular devices including Drug Eluting Balloon manufactured in Europe.Our Core mission is to build a product portfolio focused on minimally invasive treatment for patients with cardiovascular,endovascular and vascular artery disease. For further information, please visit : L2MTech.de
+49 228 94730761
FUTURE OF HEALTHCARE
M1 MedTech | April 05, 2022
M1 MedTech, a medical technology accelerator sponsored by Proxima Clinical Research, a contract research organization based out of the Texas Medical Center, announcedit is accepting applications for its fall cohort. M1 MedTech is looking for five to seven of the most promising early-stage medical device companies to participate in its three-month program. The program has closed its first fund and will be selecting companies over the summer for investments up to $100,000 as a combination of both cash and in-kind services.
“Our program is unique in that it combines acceleration capital, company building expertise, and the regulatory and clinical services of a top CRO,” says Larry Lawson, a venture partner and investor with M1. “Access to the M1 founders’ network, both within and outside of the Texas Medical Center, sets these companies up for success. There’s no better group to build a MedTech company with, period.”
“Many MedTech companies are launched by innovative first-time founders with strong scientific and medical expertise, but who have never taken a regulated product to market or built a business. After working with so many companies at various stages of this journey to market, both with Proxima CRO and with accelerators from across the country, we realized there was a gap that needed to be filled for these rising founders. They not only need regulatory and clinical assistance from experts with hundreds of success stories in this field, we found they also need assistance with design, manufacturing, business, IP, and so much more,” says Isabella Schmitt, RAC, Director of Regulatory Affairs for Proxima CRO and Principle at M1. “These rising founders need to know what they don’t know; so, we put a lot of thought into what emerging companies and rising executives really need, and from that, we built the M1 curriculum.”
M1 MedTech was created to support early-stage medical device companies, offering an immersive experience that provides tangible benefits to participating companies. The program will take on a limited number of enterprises in each cohort and offer a direct approach to helping founders advance their companies and technologies. The coaching process will include a curated educational program, interactive workshops where participants can continually build out specific company deliverables, and tailored one-on-one mentoring.
“This is a very personalized program for early-stage companies focused on Class II and III medical devices,” said Sean Bittner, PhD, ACC, Director of Programs at M1 MedTech. “We’re excited to welcome our first cohort this August. The medical device companies that fit best with our program are in pre-seed or seed-stage, have completed a customer evaluation, know the issues they want to address, have not progressed far enough through the pipeline to have communicated with the FDA or completed preclinical or clinical testing,” says Bittner. “We would like the companies to have completed preliminary testing but have not gone too far into the product development phase.”
“This is a fantastic opportunity for an early-stage company to receive mentoring and guidance from a group of established individuals in the life sciences industry. The hands-on 12-week workshop curriculum will cover a variety of topics including company formation and management, preclinical and clinical testing, regulatory approval, among other necessary guidance as their companies begin to mature. We are excited to aid the founders in rapidly advancing toward commercialization and prepare them for critical early investment stages.”
Kevin Coker, CEO at Proxima CRO and Principal at M1 MedTech
Experts from Greenlight Guru, Medrio, Galen Data, and Merge Medical Device Studio join Proxima CRO as sponsors of the program and will assist with content delivery and mentoring. Applications will remain open until May 31.
About M1 MedTech
M1 MedTech is an accelerator/incubator designed to build MedTech companies. The program offers capital, entrepreneurial expertise, and CRO services, as well as an immersive experience offering a hands-on approach to guide founders as they become MedTech executives and advance their companies and technologies. The coaching process includes a curated educational program with a focus on regulatory and quality dynamics, one-on-one mentoring, and interactive workshops where participants can continually build out specific company deliverables.
PulsePoint | July 06, 2021
PulsePoint, a technology company revolutionizing health decision-making in real-time, today announced the next generation launch of its digital media buying platform, Life by PulsePoint™. Its enhanced AI and automation simplifies and supercharges the media planning, activation, and optimization processes. Designed for the self-serve programmatic trader, these updates promote efficiencies and surface predictive and in-flight campaign analytics for quick strategic decisioning to yield higher media return on investment.
Built upon PulsePoint's extensive data foundation, Genome™, that proactively uses microdata to capture attention when intent is signaled, Life is the leading healthcare end-to-end programmatic platform. Life's automated machine learning and AI allows marketers to quickly create highly-customized segments that classify populations in real-time, and deliver sequential messaging to drive customer actions in the moment and across the health journey.
This next generation of the Life platform includes:
• Advanced media planning innovations: Life offers an AI-powered forecasting tool used to run simulations to generate predictive performance metrics and intelligent audience insights. This makes it easier for marketers to preview budgets and ideate and adjust tactics to obtain their desired campaign outcomes, all before a single dollar is spent. Each forecast is powered by detailed supply and channel insights, like expected delivery, and campaign performance can be viewed by a variety of dimensions, including creative types, domains/apps, condition categories, healthcare professional specialties, geographies, among others.
• Better campaign management with advanced dashboard: An automated and real-time view of line item performance and pacing gives traders a deeper, more granular look into their campaigns, making it easier for them to optimize their spend based on flight delivery and anticipate new incremental opportunities. The dashboard not only surfaces key numbers, but it also includes dynamic performance charts to uncover real-time campaign insights.
• Turnkey PMP (private marketplaces) deal builder: Enhanced with turnkey end-to-end functionality, self-serve traders can now enable the deals that they negotiated directly with publishers and/or SSPs through Life's UI, decreasing the time it takes to launch PMPs.
"Life was built for the healthcare marketer to simplify and optimize marketing campaigns," said Andrew Stark, CRO of PulsePoint. "Our newest capabilities increase efficiencies through advanced forecasting and real-time performance optimization, enabling more control and enhanced campaign management."
Life by PulsePoint provides access to over 110 billion daily impressions across more than 2 million health pages, reaching 1.8M+ opted-in, verified healthcare professionals and over 90% of the online U.S. population. This release is just another step in PulsePoint's journey to deliver personalized messaging at each stage of the health journey using predictive insights built on real-time data.
The company was recently acquired by Internet Brands, a KKR portfolio company and owner of WebMD Health Corp. PulsePoint's teams will continue to operate as their own division from their existing hubs in New York, San Francisco, and London.
PulsePoint is a leading technology company that uses real-world data in real-time to optimize campaign performance and revolutionize health decision-making. Leveraging proprietary datasets and methodology, PulsePoint targets healthcare professionals and patients with an unprecedented level of accuracy—delivering unparalleled results to the clients we serve.
FUTURE OF HEALTHCARE
Aatru Medical | April 28, 2022
Aatru Medical is pleased to announce the acquisition of Exothermix, the inventor and supplier of the unique mode-of-action component in the NPSIMSTM incisional management negative pressure system.
Exothermix is an innovation company with patented technology and manufacturing of simple, fast, and safe oxygen scavengers with various uses including on-demand self-heating solutions that serve the medical, military, beauty, and personal care markets with these customized products.
“We are very pleased to join the Aatru family. The resulting synergies allow us to not only continue to be a key component supplier to Aatru Medical, but this also allows us to continue to develop and to manufacturer industry-changing products for our existing and future customers.”
Daniel Hancock, who will remain as President of Exothermix
The full Exothermix management and staff will remain in place in the College Station, TX facility and continue to service existing customers.
Aatru Medical President Edward Armstrong noted, “The acquisition brings together two innovative technologies and business cultures, which provides a stronger platform for future growth, through accelerated product development and the seamless integration of our supply chain.”
Aatru Medical, LLC is a privately-owned medical device company located in Cleveland, OH. The company’s recently FDA-cleared NPSIMSTM is a pre-assembled, single use solid-state negative pressure system for surgical incision management.