Investigational device exemption

Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs

Retrieved on: 
Monday, April 1, 2024
Harvard Medical School, Investigational device exemption, Human, Obesity, Cardiovascular disease, Exercise, Risk, Patient, Food and Drug Administration, Weight loss, IDE, MD, Diet, Pharmacotherapy, Duodenum, Hospital, T2D, Wellness, Pathology, Therapy, BMI, FDA, Endoscopy, Food, Pharmaceutical industry

BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced U.S. Food and Drug Administration (FDA) approval of a pivotal Investigational Device Exemption (IDE) to study Revita’s efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist (GLP-1RA) drug therapy, addressing a key unmet need in the treatment of obesity. Obesity affects over 40% of the US population and is a critical precursor to various highly morbid and expensive chronic conditions such as type 2 diabetes, metabolic dysfunction-associated fatty liver disease, and cardiovascular disease.

Key Points: 
  • The IDE approval launches the groundbreaking Remain-1 study, set to begin in the second half of 2024.
  • Remain-1 is a randomized, double-blind trial of Revita versus sham in patients who have lost at least 15% total body weight on tirzepatide therapy.
  • It is designed to be a pivotal study to potentially enable registrational filing for Revita for weight maintenance after GLP-1RA discontinuation.
  • The rationale for the Remain-1 pivotal study is based on a new need for therapeutic solutions that can offer durable weight maintenance without ongoing medical therapy.

Orchestra BioMed Reports Full Year 2023 Financial Results and Provides Fourth Quarter Business Update

Retrieved on: 
Wednesday, March 27, 2024
Research, Investigational device exemption, Orchestra, HOPE, Partnership, Physician, Patient, Calibration, ISR, Medtronic, Beat (music), Insurance, Heart failure, CNT, Safety, SAB, Hypertension, PMDA, FDA, Pharmaceutical industry

Globally, the treatment of coronary in-stent restenosis and other challenging artery disease indications is rapidly shifting toward drug-coated balloons.

Key Points: 
  • Globally, the treatment of coronary in-stent restenosis and other challenging artery disease indications is rapidly shifting toward drug-coated balloons.
  • Financial Results for the Year Ended December 31, 2023
    Cash and cash equivalents and marketable securities totaled $87.6 million as of December 31, 2023.
  • Net loss for 2023 was $49.1 million, or ($1.48) per share, compared with a net loss of $33.6 million, or ($2.24) per share, for 2022.
  • Net loss for the year-ended 2023 included non-cash stock-based compensation expense of $7.6 million, compared with $3.4 million for the same period in 2022.

Orchestra BioMed Demonstrates Strength of Cardiovascular Pipeline with Virtue® SAB and AVIM Therapy Presentations at CRT 2024 Annual Meeting

Retrieved on: 
Wednesday, March 13, 2024
Blood pressure, CRT, Investigational device exemption, HOPE, Patient, Inflammation, Stroke, Gold, Restenosis, ISR, Medtronic, Beat (music), Trial of the century, Virtue, Sirolimus, Stent, Safety, Pharmacokinetics, SAB, Hypertension, Molecular mass, Food, Medical device

A second presentation featured recently reported clinical data on atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT), an investigational therapy delivered via standard dual-chamber pacemakers designed to immediately, substantially and persistently lower blood pressure.

Key Points: 
  • A second presentation featured recently reported clinical data on atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT), an investigational therapy delivered via standard dual-chamber pacemakers designed to immediately, substantially and persistently lower blood pressure.
  • The AVIM presentation also outlined the design of the currently enrolling BACKBEAT global pivotal study evaluating AVIM therapy in hypertensive pacemaker patients in collaboration with Medtronic.
  • Specifically, the presented PK data showed that:
    Molecular weight of Sostenocel remained unchanged prior to elimination, showing no evidence of in-vivo degradation.
  • AVIM therapy demonstrated:
    Consistent favorable hemodynamic effects using both conduction system, as well as traditional right ventricular lead placements.

Sigyn Therapeutics™ Announces Filing of 2023 Annual Report on SEC Form 10-K

Retrieved on: 
Wednesday, February 21, 2024
SAN, Sepsis, Lipopolysaccharide, Toxicity, Inflammation, FDA, Form 10-K, Cardiovascular disease, Dialysis, IDE, Kidney disease, Annual report, Death, Patient, ESRD, Investigational device exemption, Mortality, Infection, Cancer, Pharmaceutical industry

SAN DIEGO, CA, Feb. 21, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – Sigyn Therapeutics, Inc. (“Sigyn Therapeutics” or the “Company”) (OTCQB: “SIGYD” – “SIGY”), a development-stage medical technology company, announced today the filing of its Form 10-K annual report with the United States Securities and Exchange Commission ("SEC") for the year-ended December 31, 2023.

Key Points: 
  • SAN DIEGO, CA, Feb. 21, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – Sigyn Therapeutics, Inc. (“Sigyn Therapeutics” or the “Company”) (OTCQB: “SIGYD” – “SIGY”), a development-stage medical technology company, announced today the filing of its Form 10-K annual report with the United States Securities and Exchange Commission ("SEC") for the year-ended December 31, 2023.
  • The annual report can be accessed on the SEC's website at www.sec.gov or on the Company's website at www.sigyntherapeutics.com under the "investors" section.
  • On January 31, 2024, the Company completed a 1-for-40 reverse split of its common stock.
  • In 2023, net cash used in operating activities was approximately $1.4 million, as compared to approximately $1.8 million in 2022.

Reverse Hip Replacement System Unveiled at Global Orthopedic Surgery Meeting

Retrieved on: 
Thursday, February 15, 2024
JIS, SAN, Collection, Division, Total, PROM, Roentgen stereophotogrammetry, MD, Physician, FDA, Effectiveness, Orthopedic surgery, Quality of life, Shore Medical Center, Dislocation, HRS, IDE, Eye, Entrepreneurship, RSA, Agency, Risk, Narration, Safety, Arthralgia, THA, Patient, HIT, Hip, Investigational device exemption, AAOS, Reverse, Roentgen, Motion, American Academy, Medical device

SAN FRANCISCO, Feb. 15, 2024 /PRNewswire/ -- Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients, today announced that its flagship product, the Reverse Hip Replacement System (Reverse HRS) was showcased at the 2024 American Academy of Orthopaedic Surgeons (AAOS) annual meeting, taking place in San Francisco, CA from February 12 -16, 2024.

Key Points: 
  • "We are extremely excited that the Reverse HRS was featured at AAOS in the OrthoDome with a video of an actual hip replacement surgery narrated by Dr. Adolph Lombardi," said George Diamantoni, Hip Innovation Technology's Co-Founder and Chief Executive Officer.
  • The presentation featured high resolution video of Dr. Lombardi conducting a hip replacement with the new Reverse HRS.
  • The Bone & Joint Open journal, recently published the article, "Radiostereometric analysis and clinical outcomes of a novel reverse total hip system at two years."
  • Hip replacement surgery, or total hip arthroplasty, is one of the most common joint replacement procedures done in the United States.

ZKR Orthopedics Receives IDE Approval for Clinical Trial

Retrieved on: 
Wednesday, February 14, 2024
SAN, Incidence, Degenerative disease, Stair climbing, Orthopedic surgery, FDA, Obesity, Pain, Mutation, Swelling, Exercise, IDE, Visual analogue scale, Conference, Prevalence, Safety, Elective surgery, Canaccord Genuity, Patient, Knee, Cadaver, Investigational device exemption, AAOS, American Academy, Pharmaceutical industry

SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial.

Key Points: 
  • SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial.
  • We expect the data collected by this trial will establish a strong foundation of compelling clinical evidence for the LIFT implant approval for clinical use," commented David Cash, CEO of ZKR Orthopedics.
  • The IDE approval announcement was made as part of the ZKR Orthopedics activities at the 2024 American Academy of Orthopedic Surgeons annual meeting in San Francisco.
  • In addition to reporting IDE trial approval, the Company participated in the Canaccord Genuity Musculoskeletal Conference earlier this week.

Microbot Medical Submits an IDE Application to Gain FDA Approval to Commence Its Pivotal Clinical Trial in the US

Retrieved on: 
Monday, February 5, 2024
Clinical trial, Food, Investigational device exemption, IDE, FDA, Medical device

BRAINTREE, Mass., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the LIBERTY® Endovascular Robotic Surgical System, announced that it has filed an Investigational Device Exemption (IDE) application with the US Food and Drug Administration (FDA).

Key Points: 
  • BRAINTREE, Mass., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the LIBERTY® Endovascular Robotic Surgical System, announced that it has filed an Investigational Device Exemption (IDE) application with the US Food and Drug Administration (FDA).
  • The IDE application follows the completion of multiple preclinical activities performed to provide preliminary safety and effectiveness information, and its approval by the FDA would allow the company to commence its pivotal human clinical trial in the United States.
  • “This is an important milestone for the company, and it is another step forward in our journey to achieve FDA clearance for the LIBERTY® Endovascular Robotic Surgical System,” said Harel Gadot, CEO, President and Chairman of Microbot Medical.

USGI Medical Receives FDA Approval to Conduct Pivotal Study of the POSE2.0® Incisionless Weight Loss Procedure for Primary Obesity

Retrieved on: 
Wednesday, January 31, 2024
Interim, Principal, Weight loss, SAN, IOP, Mayo Clinic, Obesity, Clinical trial, Patient, Safety, Investigational device exemption, FDA, MPH, Hypertension, Stomach, Body mass index, Diabetes, University, Principal investigator, Bariatric surgery, IDE, Pharmaceutical industry

SAN CLEMENTE, Calif., Jan. 31, 2024 (GLOBE NEWSWIRE) -- USGI Medical, Inc. (USGI), the pioneer of incisionless weight loss procedures and devices, announced today that the United States Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application to conduct a pivotal study of its POSE2.0® incisionless procedure for primary obesity.

Key Points: 
  • SAN CLEMENTE, Calif., Jan. 31, 2024 (GLOBE NEWSWIRE) -- USGI Medical, Inc. (USGI), the pioneer of incisionless weight loss procedures and devices, announced today that the United States Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application to conduct a pivotal study of its POSE2.0® incisionless procedure for primary obesity.
  • POSE2.0® uses USGI Medical’s Incisionless Operating Platform (IOP) to strategically place durable Snowshoe Suture Anchors in gastric tissue to both shorten and narrow the stomach.
  • Barham Abu Dayyeh, M.D., MPH, of Mayo Clinic (Rochester, Minn.), is expected to lead the new INSPIRO pivotal study as Principal Investigator.
  • Erik Wilson, M.D., Medical Director of Bariatric Surgery at the University of Texas McGovern Medical at Houston, will serve as Co-Principal Investigator.

Vivasure Medical Announces First Patients Treated with PerQseal Elite Closure Device System

Retrieved on: 
Tuesday, December 12, 2023
Cardiology, Radiology, Surgery, General Health, Health, Medical Devices, Health Technology, Clinical Trials, TAVR, Safety, Calcium, Elite, ELITE, CAD, Aortic stenosis, Patient, Stenosis, EVAR, IDE, Trial of the century, TEVAR, Investigational device exemption

Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient treated with PerQseal® Elite, the latest generation of the company’s fully absorbable large-hole closure system.

Key Points: 
  • Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient treated with PerQseal® Elite, the latest generation of the company’s fully absorbable large-hole closure system.
  • Ph.D., at Erasmus University Hospital in Rotterdam, The Netherlands, as part of the company’s ELITE Study—a prospective, multi-center, single-arm clinical study evaluating the safety and efficacy of PerQseal Elite.
  • PerQseal Elite leverages the legacy PerQseal system’s excellent safety profile and ease of use.
  • The company continues to enroll patients for its Investigational Device Exemption (IDE) clinical study for PerQseal and PerQseal+ in the United States.

BillionToOne Announces Global Collaboration to Provide its UNITY Fetal Antigen™ Clinical Trial Assay in Johnson & Johnson Phase 3 Clinical Trial of Nipocalimab in Hemolytic Disease of the Fetus and Newborn

Retrieved on: 
Tuesday, December 12, 2023
QCT, Food and Drug Administration, AZALEA, Johnson & Johnson, DNA, Food, Risk, Clinical trial, RBC, European, Anemia, LDT, FDA, Blood, IDE, Janssen Pharmaceuticals, Prenatal testing, Doctor of Philosophy, NGS, HDFN, Investigational device exemption, Kell, Fetus, Viscosity, RHD (gene), Vaccine

MENLO PARK, Calif., Dec. 12, 2023 /PRNewswire/ -- BillionToOne (BTO), a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, is pleased to announce a global collaboration with Janssen Research & Development, LLC, a Johnson & Johnson company (Johnson & Johnson), in the AZALEA Phase 3 clinical trial of nipocalimab in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN). BTO will provide its UNITY Fetal Antigen Non-invasive Prenatal Test Clinical Trial Assay (UNITY Fetal Antigen CTA), which will serve as a screening assay to help determine the eligibility of pregnant individuals to be included in the trial, which will be conducted in the United States, the European Union, and other select countries in the rest of the world. HDFN is a serious and rare condition which occurs when the blood types of a pregnant individual and the fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant.1

Key Points: 
  • "The ability to detect fetal antigens as early as 10 weeks is only made possible due to our expertise in fetal DNA quantification.
  • The UNITY Fetal Antigen CTA is just one of the many applications of our QCT technology's capabilities."
  • Earlier this year, BillionToOne also published clinical validation data of the UNITY Fetal Antigen Laboratory Developed Test (LDT)2.
  • Additionally, the UNITY Fetal Antigen LDT results were 100% concordant with corresponding neonatal antigen genotype/serology for 23 RhD-negative pregnant individuals and 93 antigen evaluations in 30 alloimmunized pregnancies.2