Surgery

Global Collagen & Gelatin (Bovine, Porcine, Marine) Markets, 2021-2026: Focus on Wound Care, Orthopedic, Cardiovascular Disease, Dental, Surgical, Dural - ResearchAndMarkets.com

Tuesday, July 27, 2021 - 11:51am

The "Global Collagen & Gelatin Market by Source (Bovine, Porcine, Marine), Application (Wound Care, Orthopedic, Cardiovascular Disease, Dental, Surgical, Dural), End-user (Hospitals, Surgical Centers), and Region - Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Collagen & Gelatin Market by Source (Bovine, Porcine, Marine), Application (Wound Care, Orthopedic, Cardiovascular Disease, Dental, Surgical, Dural), End-user (Hospitals, Surgical Centers), and Region - Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.
  • The global collagen and gelatin market is projected to reach USD 1,083 million by 2026 from USD 772 million in 2021, at a CAGR of 7% during the forecast period.
  • Based on application, the global collagen market is segmented into orthopedic, wound care, dental, surgical, cardiovascular, and other applications.
  • The collagen and gelatin market in the Asia Pacific region is expected to grow at the highest CAGR during the forecast period.

XyloCor Therapeutics Commences Phase 2 Component of Phase 1/2 EXACT Clinical Study of XC001 Gene Therapy for Refractory Angina

Tuesday, July 27, 2021 - 12:00pm

XyloCor also confirms that it plans to submit an additional Phase 2 clinical study to the U.S. Food and Drug Administration (FDA) for XC001 as adjunctive therapy to coronary artery bypass grafting (CABG) in 2H21.

Key Points: 
  • XyloCor also confirms that it plans to submit an additional Phase 2 clinical study to the U.S. Food and Drug Administration (FDA) for XC001 as adjunctive therapy to coronary artery bypass grafting (CABG) in 2H21.
  • It is very exciting to now move forward with exploring XC001s potential in the Phase 2 portion of EXACT as a one-time therapy for patients with refractory angina.
  • XyloCor commenced the EXACT Trial, a Phase 1/2 study of XC001 in chronic refractory angina, in 2020.
  • The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial is a Phase 1/2 multicenter, open-label, single-arm, dose-escalation trial.

Cardiovascular Systems, Inc. to Attend Three Investor Conferences in August

Tuesday, July 27, 2021 - 12:00pm

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease.

Key Points: 
  • Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease.
  • The companys orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives.
  • For additional information, please visit www.csi360.com and connect on Twitter @csi360.
  • View source version on businesswire.com: https://www.businesswire.com/news/home/20210727005130/en/

Harrow Health Acquires Patented Ophthalmic Surgical Drug Candidate from Sintetica

Tuesday, July 27, 2021 - 12:00pm

Sintetica intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in late 2021.

Key Points: 
  • Sintetica intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in late 2021.
  • Harrow Health will have marketing rights for the U.S. and Canada, while Sintetica will retain the marketing rights in other countries.
  • Harrow Health also holds equity positions in Eton Pharmaceuticals, Surface Ophthalmics and Melt Pharmaceuticals, all of which started as Harrow Health subsidiaries.
  • Harrow Health also owns royalty rights in four clinical stage drug candidates being developed by Surface Ophthalmics and Melt Pharmaceuticals.

Olney Center for Oral and Maxillofacial Surgery Introduces New Technology For Facial Cosmetic Procedures

Tuesday, July 27, 2021 - 10:00am

This procedure was added to Olney Center for Oral and Maxillofacial Surgery services due to Dr. Tebyanian's interest in assisting his patients in achieving a youthful appearance.

Key Points: 
  • This procedure was added to Olney Center for Oral and Maxillofacial Surgery services due to Dr. Tebyanian's interest in assisting his patients in achieving a youthful appearance.
  • This led to Olney Center for Oral and Maxillofacial Surgery's announcement of their deployment of new groundbreaking technology, called EmbraceRF.
  • The EmbraceRF procedures are best for:
    Patients who had facial cosmetic surgery but have relapses and need maintenance.
  • Dr. Anis Tebyanian is a highly regarded, board-certified Oral and Maxillofacial Surgeon that specializes in oral and maxillofacial surgery, anesthesia, general surgery, plastic surgery, head, and neck surgery, and facial trauma.

TA Associates Announces Strategic Growth Investment in Elos Medtech

Tuesday, July 27, 2021 - 6:30am

TA Associates, a leading global growth private equity firm, today announced it has completed a majority growth investment in Elos Medtech AB (NASDAQ STOCKHOLM: ELOS B), a leading innovative full-service contract development and manufacturing organization (CDMO) in the global medical device market.

Key Points: 
  • TA Associates, a leading global growth private equity firm, today announced it has completed a majority growth investment in Elos Medtech AB (NASDAQ STOCKHOLM: ELOS B), a leading innovative full-service contract development and manufacturing organization (CDMO) in the global medical device market.
  • We have followed Elos Medtech for several years and have been highly impressed by the company and its management team, said Lovisa Lander, a Principal at TA.
  • We look forward to working with the Elos Medtech team to solidify its position as a global, high-quality development and manufacturing partner with a MedTech focus.
  • I am very pleased to welcome TA as the majority shareholder of Elos Medtech, said Jan Wahlstrm, CEO of Elos Medtech.

Asensus Surgical Announces the Appointment of Two New Board Members

Monday, July 26, 2021 - 11:55am

She currently serves as the Deputy Chief Clinical Officer at Anthem, Inc., a position she has held since December 2020.

Key Points: 
  • She currently serves as the Deputy Chief Clinical Officer at Anthem, Inc., a position she has held since December 2020.
  • She completed her residency in Preventive Care at Harvard Preventive Care and is Board Certified in Preventive Care and Occupational Medicine.
  • I am thrilled to join the Asensus Surgical Board of Directors at such an important time for the company, said Mr. Hobert.
  • This builds upon the foundation of Digital Laparoscopy with the Senhance Surgical System powered by the Intelligent Surgical Unit (ISU) to increase surgeon control and reduce surgical variability.

PolarityTE Submits Investigational New Drug Application for SkinTE® in Chronic Cutaneous Ulcers

Monday, July 26, 2021 - 1:00pm

PolarityTE, Inc. (Nasdaq: PTE) today announced the submission of an investigational new drug application (IND) to the United States Food and Drug Administration (FDA) seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers.

Key Points: 
  • PolarityTE, Inc. (Nasdaq: PTE) today announced the submission of an investigational new drug application (IND) to the United States Food and Drug Administration (FDA) seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers.
  • Wounds closed with SkinTE have exhibited significant improvement after SkinTE application (e.g., avoidance of amputation after failure of treatment alternatives).
  • Thus, PolarityTE believes that preliminary clinical evidence suggests SkinTE could ameliorate a number of serious conditions caused by chronic cutaneous ulcers.
  • POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES SELF and WELCOME TO THE SHIFT are registered trademarks of PolarityTE, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210726005157/en/

InGeneron Reports First-In-Human Microscopic Evidence of Adult Tendon Regeneration Following Autologous Stem Cell Treatment

Monday, July 26, 2021 - 1:00pm

This newly-released research paper, titled First Immunohistochemical Evidence of Human Tendon Repair Following Stem Cell Injection: A Case Report and Review of Literature , was published in the World Journal of Stem Cells on July 23, 2021 (DOI: https://dx.doi.org/10.4252/wjsc.v13.i7.944 ).

Key Points: 
  • This newly-released research paper, titled First Immunohistochemical Evidence of Human Tendon Repair Following Stem Cell Injection: A Case Report and Review of Literature , was published in the World Journal of Stem Cells on July 23, 2021 (DOI: https://dx.doi.org/10.4252/wjsc.v13.i7.944 ).
  • The analysis strongly indicates regenerative healing of the tendon, resulting from transformation of UA-ADRCs into new tendon tissue.
  • Importantly, the investigated tendon showed evidence of histological regeneration without scar formation, a finding indicating significant advantages over existing treatments options.
  • The microscopic images of the tendon treated with stem cells clearly demonstrate that a different type of healing had taken place.

Evren Technologies receives FDA Breakthrough Device Designation for the Phoenix® - Revolutionary Transcutaneous Auricular Vagus Nerve Therapy to Treat PTSD

Monday, July 26, 2021 - 6:54pm

GAINESVILLE, Fla., July 26, 2021 /PRNewswire/ -- Evren Technologies, Inc. announced today that its non-invasive Phoenix earbud device received Breakthrough Device Designation from the U.S. Food and Drug Administration for the treatment of Post-traumatic Stress Disorder (PTSD).

Key Points: 
  • GAINESVILLE, Fla., July 26, 2021 /PRNewswire/ -- Evren Technologies, Inc. announced today that its non-invasive Phoenix earbud device received Breakthrough Device Designation from the U.S. Food and Drug Administration for the treatment of Post-traumatic Stress Disorder (PTSD).
  • 7.5 million Americans seek treatment for PTSD every year and the rates tripled during the COVID shutdown.
  • The Phoenix is an earbud that provides personalized medicine that addresses the underlying autonomic imbalance of PTSD by delivering transcutaneous auricular vagal nerve stimulation (taVNS) in a proprietary closed-loop system.
  • The Phoenix medical device provides personalized medicine in a discreet earbud design that delivers transcutaneous auricular vagal nerve stimulation (taVNS).