Aegea Medical raises $40m

Aegea Medical said today raised a total of $40 million in financing to support the development of its Adaptive Vapor Ablation technology designed for endometrial ablation.

The Redwood City, Calif.-based company said the financing included $30 million from Perceptive Advisors and an additional $10 million from existing equity investors including Medtronic (NYSE:MDT), Alloy Ventures, Delphi Ventures, BioMed Ventures and Solas BioVentures.

“We are excited to be partnering with Aegea Medical in helping to launch this game-changing technology in the women’s health space. We believe Aegea’s Adaptive Vapor technology has great potential for addressing and expanding the market for endometrial ablation, and we look forward to working with Aegea to achieve these objectives,” Perceptive portfolio manager Sam Chawla said in a press release.

The Adaptive Vapor Ablation system is an FDA-approved endometrial ablation system designed to treat menorrhagia in an in-office setting with only mild anesthesia and analgesia, Aegea said.

Financing from the round will help prepare to launch the device commercially in the US, the company said.

“Aegea is at an important inflection point as we prepare to transform the experience for the millions of women suffering from abnormal uterine bleeding, and the physicians that serve them. We are delighted to partner with Perceptive Advisors as we prepare to launch this novel and disruptive technology,” prez & CEO Don Gurskis said in a prepared statement.

The post Aegea Medical raises $40m appeared first on MassDevice.

from MassDevice http://ift.tt/2CG3lNG

Artificial lung dev Breethe raises $3m

Artificial lung developer Breethe raised approximately $3 million in an equity financing round, according to an SEC filing posted late last month.

Funds raised during the round will cover the sales and issuance of Series Seed-4 preferred stock and the underlying common stock convertible from it, according to the filing.

The Baltimore-based company is developing the Oxy-1 ambulatory artificial lung system which is designed for home use for patients who suffer from acute and chronic lung failure, according to its website.

The system includes a portable pack, which contains the unit’s batteries, oxygen source and pump motor and controller, a pump-lung unit which it anticipates will need to be replaced every 30 days and a blood cannula connection to the heart.

Breethe was formed in 2014 as a spin-out from the University of Maryland, Baltimore, utilizing licensed technology from the University.

A total of 22 anonymous investors joined the $3 million round, according to the filing, with the first sale date recorded on December 13.

The company is not looking to raise any more funds in the round and hasn’t officially announced the round outside the SEC filing.

The post Artificial lung dev Breethe raises $3m appeared first on MassDevice.

from MassDevice http://ift.tt/2lHkVZw

RenalGuard Solutions touts first-in-man heart failure device study results

RenalGuard Solutions today touted results from a first-in-man feasibility study of its RenalGuard System designed to manage fluids during diuretic therapy to treat congestive heart failure in patients suffering from fluid overload.

Results from the trial were presented at the annual Devices in Heart Failure congress in Berlin, Germany, the Milford, Mass.-based company said.

The company’s RenalGuard device is designed to measure urine output and automatically infuse hydration fluid based on those measurements, aiming to induce high urine rates to protect the kidneys, the company said.

Data from the study followed the treatment of 10 diuretic resistant patients with heart failure symptoms receiving diuretic therapy while fluid management was controlled by the RenalGuard system.

“None of the patients we treated experienced a fluid loss rate greater than the settings we established. RenalGuard Therapy is remarkably simple and safe, and works automatically to carefully achieve and control the desired fluid balance,” Dr. Piotr Ponikowski, who co-presented the results of the study, said in a prepared statement.

“There is a clear unmet clinical need for alternative methods of fluid removal with superior efficacy in patients with heart failure. This first-in-man study demonstrated that RenalGuard can safely be used in these patients while maintaining the proper conditions to both prevent diuretic resistance, and increase the removal of excess fluid from the patient. Our initial experience with the RenalGuard System in heart failure patients is very promising, and we look forward to advancing our understanding of the benefits of this therapy to patients at risk,” Dr. Felix Mahfoud, who co-presented the results of the study, said in a prepared release.

The RenalGuard system has won CE Mark approval in the European Union, and is being used in a pivotal study in the US as the company seeks premarket approval with the FDA, which it hopes to file this year.

“These presentations demonstrate that the RenalGuard Therapy is a viable potential treatment for patients suffering from fluid overload from congestive heart failure. The results add to a growing body of evidence supporting the use of RenalGuard as a platform technology to improve cardiac and renal care for a wide range of patients, including cath lab, cardiac surgery, and now congestive heart failure,” CEO Jim Dillon said in a press release.

Last March, RenalGuard said it raised a $14.5 million Series A round for a pivotal trial of its device to prevent acute kidney injury during percutaneous procedures.

The post RenalGuard Solutions touts first-in-man heart failure device study results appeared first on MassDevice.

from MassDevice http://ift.tt/2ECeZcS

Frequency touts first-in-human safety study for hearing loss therapy

Frequency Therapeutics has finished a first-in-human study of its progenitor cell activation therapy, FX-322, in nine adults with severe to profound sensorineural hearing loss.

The company’s candidate is a combination of small molecules that are designed to activate progenitor cells and trigger the formation of new hair cells in the inner ear.

Get the full story at our sister site, Drug Delivery Business News.

The post Frequency touts first-in-human safety study for hearing loss therapy appeared first on MassDevice.

from MassDevice http://ift.tt/2qeRsvp

Align Tech shares ranked 2nd on S&P 500 for 2017, sees shares grow 131%

Clear orthodontic correction device maker Align Technology (NSDQ:ALGN) saw its shares rise 131% last year, making it second on the S&P 500 rankings for the full-year 2017, according to a Seeking Alpha report.

The company was only slightly behind the front-runner, power company NRG, who saw shares grow 132.3% over the year, according to the report.

Also in the top 20 was Sunnyvale, Calif.-based robotic surgical developer Intuitive Surgical (NSDQ:ISRG), which saw its shares grow 72.6% over the year, according to Seeking Alpha.

The only medtech-related firm in the bottom 20 of the S&P 500 was the conglomerate GE (NYSE:GE), who saw shares shrink 44.8% during 2017, according to the report.

In Dow standings for 2017, Johnson & Johnson (NYSE:JNJ) was the only medtech company to breach the top 20, ranking in at 16 with a 21.2% increase, according to a separate report from Seeking Alpha.

The post Align Tech shares ranked 2nd on S&P 500 for 2017, sees shares grow 131% appeared first on MassDevice.

from MassDevice http://ift.tt/2Cdzo6x

Coloplast picks up French distribution co Lilial for $43m

Coloplast (CPH:COLO B) said last month it acquired French direct-to-consumer distribution company Lilial for approximately $42.8 million (EU €35.5 million).

The France-based distribution company has approximately 80 employees and is expected to report sales of approximately $40 million for its full-year 2017, according to Denmark-based Coloplast.

Coloplast said the acquisition is a continuation of its goal to bring products and services to its end users, and strengthents its position in France.

“The acquisition of SAS Lilial is part of our strategy of pursuing inorganic opportunities to accelerate growth and to strengthen our service offerings. By acquiring Lilial we further strengthen our position in France and ensure our end users access to innovative products and services. Lilial is a great match for Coloplast, and I am very happy to welcome Lilial to the Coloplast family,” CEO Lars Rasmussen said in a press release.

In early December, Coloplast said it inked a definitive agreement to purchase urological device supplier Comfort Medical for $160 million.

The post Coloplast picks up French distribution co Lilial for $43m appeared first on MassDevice.

from MassDevice http://ift.tt/2Cewj6j

Stealthy endovascular dev Provisio Medical raises $4m

Stealthy endovascular device developer Provisio Medical has raised $4 million in a new round of Series B preferred stock, according to an SEC filing posted this week.

Provisio has not released any information on its developments outside its focus on endovascular therapy, which it displays on its website.

The company is headed by former Volcano Corp clinical and medical affairs VP Steven Ryan, according to the SEC filing. Prior to his time with Volcano, Ryan was founder & prez for CorNova, and served as acting medical director for AxSun Technologies, according to LinkedIn.

The San Diego, Calif.-based company is looking to raise an additional $1 million to bring the total raised up to $5 million, according to the SEC filing.

The first sale in the offering was noted on December 19, according to the filing, with 27 anonymous investors involved in the round.

A total of $450,000 from the fundraising has been earmarked for executive officer salaries, including patent assignment bonuses, according to the SEC filing.

The post Stealthy endovascular dev Provisio Medical raises $4m appeared first on MassDevice.

from MassDevice http://ift.tt/2CwNrYo