FDA clears Gelesis weight-loss hydrogel pill Plenity

 

[Image from Gelesis]

Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug.

 

The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without comorbidities like hypertension, type 2 diabetes or dyslipidemia. The company says that there is no restriction on how long the drug can be used in weight management.

“This FDA clearance is a major milestone for the Gelesis team and our technology, and we are thrilled to be able to bring this new prescription product to the millions of people looking for a safe, validated and convenient treatment option to manage their weight without surgery or stimulants,” Yishai Zohar, founder and CEO of Gelesis, said in a press release. “With Plenity, Gelesis is introducing a completely new approach with a unique mechanism of action to aid in weight management, with efficacy and safety supported by positive data from large clinical studies.”

Plenity is taken in the form of capsules with water before lunch and dinner. It is made by cross-linking cellulose and citric acid to make a 3D hydrogel matrix. When taken, the capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach to create small gel pieces that have the elasticity of plant-based foods with no calories. The gel pieces help by increasing the volume and elasticity of the stomach and small intestine, helping the body feel more full to induce weight loss.

“More than 150 million Americans struggle with excess or unhealthy weight. Unfortunately, the majority of individuals with weight issues have important weight-related medical problems. There is no doubt that making a significant impact on this issue should be America’s number one public health priority,” said Dr. Ken Fujioka, a weight loss expert and endocrinology researcher at Scripps Clinic and scientific advisor to Genesis. “The scientific data supporting PLENITY’s positive effects on weight make it a powerful tool to help with weight management. The most compelling aspects of this approach are its effectiveness, novel mechanism of action and impressive safety data. This approach creates another arm in the treatment algorithm of weight management and could be used by an overwhelming majority of people struggling with weight issues.”

The drug, which is a non-stimulant and non-systemic treatment for obesity, has been shown in clinical studies as being effective, safe and well-tolerated. The studies showed that Plenity had a combination of effectiveness and highly favorable safety and tolerability profile.

“Given the complexity of the disease of obesity and the need for expanded treatment options, the Obesity Action Coalition is encouraged to see continued innovation in safe and effective chronic weight management options. We welcome Plenity’s addition as a treatment option for people affected by obesity,” Joe Nadglowski, president and CEO of the Obesity Action Coalition.

from MassDevice http://bit.ly/2P8ded6

U.K. government requests Brexit deadline extension

By Ronald Boumans, Emergo Group

The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

from MassDevice http://bit.ly/2IlBbNs

EO plant shutdown leads to pediatric breathing tube shortage

Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)

The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.

The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.

Get the full story on our sister site, Medical Design & Outsourcing.

from MassDevice http://bit.ly/2UzbkYX

NuVasive launches X360 lateral single-position surgery device

NuVasive Inc. (NSDQ:NUVA) said yesterday that it launched its X360 system intended for lateral single-position surgery in the U.S.

The newly launched X360 system features improvements intended to accommodate advanced techniques and technologies for enhanced operating room workflow and efficiency, the San Diego-based company said.

The system also features integration with NuVasive’s Pulse surgical automation platform to allow surgeons to perform multiple procedures from the lateral position.

“X360 has transformed my approach to treating patients, allowing me to customize my surgical workflow, reduce patient anesthesia time, and efficiently treat the patient in a single, lateral position. Integrating planning, imaging, navigation, and automation throughout this entire surgical approach has become an integral component to the clinical outcomes of my patients,” Dr. Anand Veeravagu of Stanford University Medical Center said in a prepared statement.

NuVasive touted that because the system allows surgery to be performed without repositioning, it can reduce operating times by up to 60 minutes, saving hospitals on average of approximately $5,000 per patient.

“The X360 system is the most comprehensive approach to lateral single-position surgery available on the market. NuVasive continues to extend its global leadership position in lateral surgery with the integration of X360 and Pulse, the only surgical automation platform designed for spine surgery. By incorporating Pulse and, in the future, robotic automation, with X360, we are enhancing the overall OR workflow and helping surgeons deliver greater clinical predictability and reproducible outcomes for their patients,” NuVasive prez Matt Link said in a press release.

In February, NuVasive said that it won FDA 510(k) clearance and CE Mark clearance in the European Union for its Precice bone transport system.

from MassDevice http://bit.ly/2IzVHtn

Stryker wins FDA PMA, launches Lifepak CR2 AED

Stryker (NYSE:SYK) said yesterday that it launched its Lifepak CR2 defibrillator featuring the LifelinkCentral AED program manager after winning FDA premarket approval for the system.

The newly launched Lifepak CR2 AED features new technology including CPRInsight, which allows users to continue chest compressions during ECG analysis and can improve survival outcomes, the Kalamazoo, Mich.-based company said.

The Lifepak CR2 AED also features a child mode button to reduce defibrillation energy for pediatric patients and an optional bilingual feature.

The system can be connected to the LifelinkCentral AED program manager to allow an organizations AED manager to remotely monitor and manage the device to improve readiness, Stryker said.

“In order to save more lives from sudden cardiac arrest, we must save time. The Lifepak CR2 is designed to help rescuers provide higher quality CPR and to provide the fastest first shock when defibrillation is needed. Everything about it is designed to increase user confidence. The Lifepak CR2 harnesses the benefits of connectivity to provide a foundation for better care throughout the entire chain of survival and to simplify AED program management for our customers,” Stryker emergency care public access GM Ryan Landon said in a press release.

The Lifepak CR2 was previously released in Europe and Canada in 2017 and in Japan in 2018, Stryker said.

In March, Stryker said that it put $220 million on the table for OrthoSpace and its InSpace rotator cuff repair device.

from MassDevice http://bit.ly/2v2FQeE

TissueTech raises $55m

TissueTech has raised approximately $55.3 million in a new round of equity financing, according to a recently posed SEC filing.

The Doral, Fla.-based company makes amniotic membrane- and umbilical cord-based products designed to treat ocular surface diseases (its Bio-Tissue subsidiary) and musculoskeletal conditions and wound care (its Amniox Medical business).

Money in the round came from three unnamed investors, with the first sale dated as having occurred on April 9, according to the filing.

The company is looking to raise an additional $27 million, which would bring the total raised up to approximately $82.3 million, according to the SEC filing.

TissueTech said that it plans to use a $10 million of the proceeds to repurchase from common stockholders on a pro rata basis, according to the SEC filing.

The company has not yet announced any other plans for the funds.

from MassDevice http://bit.ly/2IB7kQP

FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix

Collagen Matrix said today that it won FDA 510(k) clearance for its line of OssiMend Bioactive Moldable bone graft matrix products, intended for use in spinal procedures.

The Oakland, N.J.-based company said that the newly cleared OssiMend product is composed of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen, and that it can be molded into putty for filling irregular defect sites.

The moldable Ossimend product is designed to be slowly resorbed and replaced by new bone tissue, and comes in various sizes, Collagen Matrix said.

“We continue to expand our product portfolio for the Spine market with the development of this unique line of Bioactive bone graft matrices that combines a carefully-selected ratio of three powerful components. This innovative moldable version offers surgeons options for better ensuring predictable outcomes,” CEO Bart Doedens said in a press release.

from MassDevice http://bit.ly/2P5udNj