Amputation

Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System for Treating de novo or Restenotic Below-the-Knee (BTK) Lesions

Retrieved on: 
Tuesday, January 16, 2024

Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System .

Key Points: 
  • Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System .
  • The device is intended to treat de novo or restenotic lesions in the infrapopliteal arteries with a commercially available drug-coated balloon (DCB) to enhance drug absorption.
  • View the full release here: https://www.businesswire.com/news/home/20240116803175/en/
    The Bare Temporary Spur Stent System is a unique clinical solution known as Retrievable Stent Therapy, or RST.
  • The Bare Temporary Spur Stent System is a unique clinical solution intended to provide stent-like results while leaving no metal behind.

Challenged Athletes Foundation Joins In Motion Events for the First Official Inclusive Kids Marathon Mile at LEGOLAND® California Resort

Retrieved on: 
Wednesday, January 10, 2024

SAN DIEGO, CA, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Celebrating its 30th anniversary of empowering individuals through sports, the Challenged Athletes Foundation (CAF) has partnered with, Merlin’s Magic Wand Foundation , and In Motion Events to present the first official inclusive Kids Marathon Mile on Saturday, January 13, 2024 at LEGOLAND® California Resort.

Key Points: 
  • SAN DIEGO, CA, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Celebrating its 30th anniversary of empowering individuals through sports, the Challenged Athletes Foundation (CAF) has partnered with, Merlin’s Magic Wand Foundation , and In Motion Events to present the first official inclusive Kids Marathon Mile on Saturday, January 13, 2024 at LEGOLAND® California Resort.
  • Hundreds of children with and without physical disabilities will race one mile together through LEGOLAND® California as part of the Carlsbad Marathon race weekend.
  • In collaboration with Merlin’s Magic Wand Foundation, CAF is proud to bring this unique and exclusive opportunity for participants to enjoy at LEGOLAND® California.
  • Garcia-Tolson began his running journey as a youth athlete at this same race when it was formerly known as the Carlsbad Kids Marathon Mile.

GLP-1: Beyond Diabetes, a Blockbuster Horizon Beckons

Retrieved on: 
Wednesday, January 10, 2024

NEW YORK, Jan. 10, 2024 /PRNewswire/ -- On Sept. 20, 2019, history was made when the U.S. Food and Drug Administration approved Rybelsus as the first oral glucagon-like peptide-1 (GLP-1) agonist for type 2 diabetes (T2D). However, it wasn't just a milestone for T2D management. It was a turning point in medicine, opening the floodgates to a universe of potential therapeutic applications for this remarkable molecule. While undeniably transformative for diabetes and weight loss, GLP-1's reach now extends far beyond, likely surpassing even the wildest dreams of its creators. From Alzheimer's and Parkinson's to drug addiction, clinical trials are painting a stunning picture of GLP-1's versatility. And it doesn't stop there. Strong evidence points to opportunities in heart disease, chronic kidney disease and a plethora of other conditions. The newfound applications of this super-drug re-enforce the significant potential for Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile), with its powerful DehydraTECH(TM) drug-delivery formulation and processing technology that improves both delivery and efficacy of GLP-1 for diabetes and potentially a host of other maladies. Lexaria joins other companies, including Amgen Inc. (NASDAQ: AMGN), Eli Lilly and Company (NYSE: LLY), Roche (OTCQX: RHHBY) and WW International Inc. (NASDAQ: WW), that are committed to providing powerhouse solutions in the fields of diabetes, weight loss and more.

Key Points: 
  • GLP-1 agonists are among the hottest drugs in healthcare, with uses targeting multibillion-dollar diabetes and obesity markets and much more.
  • Lexaria Bioscience has developed DehydraTECH drug-delivery platform, which is being shown to improve pharmacokinetics of orally administered drugs.
  • Lexaria issued final data from the pilot study and is planning for multiple human and animal studies early in 2024.
  • Uncontrolled blood sugar dramatically increases the risk of devastating comorbidities, including kidney disease, vision loss, amputations, heart attacks, strokes and early death.

GLP-1: Beyond Diabetes, a Blockbuster Horizon Beckons

Retrieved on: 
Wednesday, January 10, 2024

NEW YORK, Jan. 10, 2024 /PRNewswire/ -- On Sept. 20, 2019, history was made when the U.S. Food and Drug Administration approved Rybelsus as the first oral glucagon-like peptide-1 (GLP-1) agonist for type 2 diabetes (T2D). However, it wasn't just a milestone for T2D management. It was a turning point in medicine, opening the floodgates to a universe of potential therapeutic applications for this remarkable molecule. While undeniably transformative for diabetes and weight loss, GLP-1's reach now extends far beyond, likely surpassing even the wildest dreams of its creators. From Alzheimer's and Parkinson's to drug addiction, clinical trials are painting a stunning picture of GLP-1's versatility. And it doesn't stop there. Strong evidence points to opportunities in heart disease, chronic kidney disease and a plethora of other conditions. The newfound applications of this super-drug re-enforce the significant potential for Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile), with its powerful DehydraTECH(TM) drug-delivery formulation and processing technology that improves both delivery and efficacy of GLP-1 for diabetes and potentially a host of other maladies. Lexaria joins other companies, including Amgen Inc. (NASDAQ: AMGN), Eli Lilly and Company (NYSE: LLY), Roche (OTCQX: RHHBY) and WW International Inc. (NASDAQ: WW), that are committed to providing powerhouse solutions in the fields of diabetes, weight loss and more.

Key Points: 
  • GLP-1 agonists are among the hottest drugs in healthcare, with uses targeting multibillion-dollar diabetes and obesity markets and much more.
  • Lexaria Bioscience has developed DehydraTECH drug-delivery platform, which is being shown to improve pharmacokinetics of orally administered drugs.
  • Lexaria issued final data from the pilot study and is planning for multiple human and animal studies early in 2024.
  • Uncontrolled blood sugar dramatically increases the risk of devastating comorbidities, including kidney disease, vision loss, amputations, heart attacks, strokes and early death.

Niterra Leads $10M Growth Funding Round for Imbed Biosciences

Retrieved on: 
Monday, January 8, 2024

Niterra today announced its participation in the $10M convertible debt financing for Imbed Biosciences, Inc. (Imbed) , a tissue engineering company developing advanced biomaterials for soft-tissue repair.

Key Points: 
  • Niterra today announced its participation in the $10M convertible debt financing for Imbed Biosciences, Inc. (Imbed) , a tissue engineering company developing advanced biomaterials for soft-tissue repair.
  • View the full release here: https://www.businesswire.com/news/home/20240108469239/en/
    Imbed Biosciences has developed the world’s first and only fully-synthetic and antimicrobial wound matrix, which is FDA-cleared.
  • The antimicrobial matrix provides a healing environment conducive to tissue growth and suppresses the growth of microbes and biofilms.
  • With this latest round of financing, Imbed Biosciences will further establish its position as the leading developer of advanced devices for the management of burns, wounds and soft-tissue repair.

BI Medical Seeks Strategic Buyer to Revolutionize Limb Loss Hygiene Care Worldwide

Retrieved on: 
Tuesday, November 14, 2023

Providence, Rhode Island--(Newsfile Corp. - November 14, 2023) - BI Medical, a visionary leader in the O&P healthcare industry, is seeking a strategic buyer to help scale adoption of its proprietary hygiene technology across the limb loss community, both nationally and globally.

Key Points: 
  • Providence, Rhode Island--(Newsfile Corp. - November 14, 2023) - BI Medical, a visionary leader in the O&P healthcare industry, is seeking a strategic buyer to help scale adoption of its proprietary hygiene technology across the limb loss community, both nationally and globally.
  • Revolutionizing Limb Loss Care: BI Medical is set to transform limb loss care globally through a strategic acquisition, to help scaling its innovative hygiene technology.
  • Clinical-Proof Hygiene Innovation: The Liner Wand, BI Medical's pioneering hygiene solution, clinically proves its effectiveness in reducing skin irritation and odor, significantly improving the lives of amputees.
  • BI Medical is accepting initial interest through 2/1/24 and hopes to complete the sale of the business by Q2/2024.

MediWound Announces Peer-Reviewed Publication of EscharEx® Mechanism of Action Study Assessing Its Effects on Biofilm and Microbial Loads

Retrieved on: 
Thursday, December 21, 2023

Results show that EscharEx not only effectively debrides wounds, but also reduces biofilm and bacterial load in both VLUs and DFUs.

Key Points: 
  • Results show that EscharEx not only effectively debrides wounds, but also reduces biofilm and bacterial load in both VLUs and DFUs.
  • 70% of the patients (7/10) that completed the study achieved complete debridement within a median time of 5.5 days.
  • An average reduction of 35% in wound size was achieved by the end of the 2-week follow-up period.
  • Together with the outcomes of our previous Phase II study results, this study furthers the understanding of the effects of EscharEx.

BioStem Technologies Bolsters Leadership with Appointment of Thomas Dugan to Board of Directors

Retrieved on: 
Wednesday, December 13, 2023

(OTC:BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived biologics for advanced wound care, today announces the appointment of Mr. Thomas J. Dugan to the position of Chairman of the Board.

Key Points: 
  • (OTC:BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived biologics for advanced wound care, today announces the appointment of Mr. Thomas J. Dugan to the position of Chairman of the Board.
  • Mr. Dugan brings a wealth of experience to BioStem, with proven, hands-on expertise as a senior executive who has transformed businesses, established new market opportunities, and driven growth in the face of strong competition.
  • BioStem Technologies CEO, Jason Matuszewski, said, “I am delighted to welcome Mr. Dugan to BioStem’s Board of Directors.
  • Mr. Dugan served on the board of directors of Rita Medical Systems (NASDAQ: RITA), which was acquired by AngioDynamics, and various venture-backed medical device companies.

Humacyte Submits Biologics License Application (BLA) to U.S. FDA Seeking Approval of Human Acellular Vessel™ (HAV™) for the Treatment of Vascular Trauma

Retrieved on: 
Tuesday, December 12, 2023

DURHAM, N.C., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it has submitted a Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.

Key Points: 
  • The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine.
  • The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.
  • Humacyte has requested Priority Review of the application and, if granted, the review should be completed within six months of the filing acceptance date.
  • In May 2023 the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for use of the HAV in urgent arterial repair following extremity vascular trauma.

Healed Warrior Uses His Story to Inspire Others

Retrieved on: 
Wednesday, November 22, 2023

And then they finally were able to release me from the hospital and allow me to start at the Center for the Intrepid.

Key Points: 
  • And then they finally were able to release me from the hospital and allow me to start at the Center for the Intrepid.
  • That's for sure.”
    J.P. and his wife, Crystal, now spend their time traveling and telling his story to inspire others.
  • I am literally a walking example of being able to do so much.”
    “I'm not a wounded warrior.
  • I'm just a warrior, because I'm healed, and I'm even stronger than I used to be.