Chronic pain

Treace Celebrates 100,000 Lapiplasty® 3D Bunion Correction® Patient Milestone

Retrieved on: 
Monday, March 25, 2024

PONTE VEDRA, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty® Procedures, today announced that 100,000 patients have been treated with its patented Lapiplasty® 3D Bunion Correction® System.1 This milestone coincides with the first-ever National Bunion Day in the United States, which is being sponsored by Treace on April 16, 2024, and the launch of its new patient education and brand awareness campaign.

Key Points: 
  • “Achieving this important milestone is a testament to the tireless efforts of our team members and the trust of our surgeon customers and patients, all of whom have made our journey possible,” said John T. Treace, CEO and Founder of Treace.
  • “Since our initial surgical cases in 2015, Treace has been committed to educating people about surgical options that can provide lasting relief from bunion pain through our innovative procedures that are designed to minimize recovery time, reduce recurrence rates, and improve patient outcomes.
  • Today the Company also unveiled its latest campaign to continue to drive patient education and awareness of its Lapiplasty® Procedure.
  • Treace will premiere the “Future You” commercial on the finale of “The Bachelor” TV show on March 25, 2024 at 8:00 p.m. Eastern Time on the ABC network.

Scilex Holding Company Announces New Out-of-Pocket Costs for Commercially Insured Patients

Retrieved on: 
Thursday, March 21, 2024

PALO ALTO, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that the out-of-pocket costs for its product portfolio for commercially insured patients is expected to be capped at $25 monthly, with certain eligible patients paying as low as $0.

Key Points: 
  • PALO ALTO, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that the out-of-pocket costs for its product portfolio for commercially insured patients is expected to be capped at $25 monthly, with certain eligible patients paying as low as $0.
  • Scilex is aware of the impact this disruption has had on its patients and customers and has worked diligently to resolve the issue.
  • Scilex co-pay programs is designed to help patients reduce their co-pays and out-of-pocket costs for their medication.
  • For more information on Scilex Holding Company, refer to www.scilexholding.com
    For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com .

TELA Bio Announces U.S. Commercial Launch of LIQUIFIX™ – the Only FDA-Approved Liquid Adhesive for Internal Use in Hernia Surgery

Retrieved on: 
Thursday, March 21, 2024

(NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced the U.S. launch of LIQUIFIX FIX8™ Laparoscopic and LIQUIFIX Precision™ Open Hernia Mesh Fixation Devices.

Key Points: 
  • (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced the U.S. launch of LIQUIFIX FIX8™ Laparoscopic and LIQUIFIX Precision™ Open Hernia Mesh Fixation Devices.
  • LIQUIFIX FIX8 is indicated for minimally invasive femoral and inguinal hernia repairs; and LIQUIFIX Precision is indicated for open femoral and inguinal hernia repairs.
  • The LIQUIFIX devices are the only FDA-approved devices that affix mesh and approximate peritoneal tissue with liquid anchors.
  • LIQUIFIX hernia mesh fixation devices eliminate the need for penetrating mechanical tacks, sutures, or staples by delivering a liquid adhesive that allows for precise and controlled mesh fixation.

University of South Florida research funding reaches record high of $692 million

Retrieved on: 
Wednesday, March 20, 2024

“The University of South Florida's record-breaking success in research funding is a reflection of our commitment to advancing new knowledge, fostering innovation and making a positive impact on society," USF President Rhea Law said.

Key Points: 
  • “The University of South Florida's record-breaking success in research funding is a reflection of our commitment to advancing new knowledge, fostering innovation and making a positive impact on society," USF President Rhea Law said.
  • "The dedicated work of our world-class faculty, talented research staff and collaborative partners continues to lift USF’s research enterprise to new heights."
  • USF’s funding from private partnerships grew by 11% to $218 million, while funding from state and local sources nearly doubled to $82 million.
  • “This substantial increase in research enterprise funding reflects USF’s stature as a top public research university,” said Sylvia Wilson Thomas, USF vice president for research and innovation.

Scilex Holding Company Announces a Settlement Agreement with Takeda Pharmaceuticals to Resolve the Paragraph IV Patent Infringement Lawsuit Relating to Scilex’s Filing of a sNDA with the FDA Seeking to Expand the Label for its FDA-Approved Liquid Colchici

Retrieved on: 
Wednesday, March 20, 2024

That litigation arose from Scilex’s filing of a sNDA with the FDA seeking to expand the label for its FDA-approved liquid colchicine product, Gloperba®, a preventive treatment for gout.

Key Points: 
  • That litigation arose from Scilex’s filing of a sNDA with the FDA seeking to expand the label for its FDA-approved liquid colchicine product, Gloperba®, a preventive treatment for gout.
  • As part of the Settlement Agreement, the Scilex Parties entered into a License Agreement with Takeda granting the Company and its affiliates a non-exclusive license to certain patents owned by Takeda.
  • The Settlement Agreement is subject to approval by the district court, and by both the Federal Trade Commission and the U.S. Department of Justice, as is required in Paragraph IV patent case settlements.
  • For more information on Scilex Holding Company, refer to www.scilexholding.com .

Scilex Holding Company Announces Seeking Approval from the FDA for Modification of the Gloperba® Label to Provide Specific Dosing Guidance for Patients with Renal Impairment and Other Circumstances Where Dose Adjustment is Needed

Retrieved on: 
Wednesday, March 20, 2024

For patients with severe renal impairment, the starting dose should be 0.3 mg/day.

Key Points: 
  • For patients with severe renal impairment, the starting dose should be 0.3 mg/day.
  • For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week.
  • Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.
  • For more information on Scilex Holding Company, refer to www.scilexholding.com
    For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com .

Scilex Holding Company Announces Repayment in Full of the Remaining Balance of Convertible Debentures and Early Payment of the Senior Secured Promissory Note, Paving the Way for Future Growth and Innovation

Retrieved on: 
Tuesday, March 19, 2024

$1,300,000 under the convertible debentures (the “Convertible Debentures”) previously issued and sold to YA II PN, Ltd. (“Yorkville”) in March 2023.

Key Points: 
  • $1,300,000 under the convertible debentures (the “Convertible Debentures”) previously issued and sold to YA II PN, Ltd. (“Yorkville”) in March 2023.
  • Scilex has also voluntarily made an early payment in the aggregate amount of $15,000,000 under the senior secured promissory note (the “Oramed Note”) issued to Oramed Pharmaceuticals Inc. (Nasdaq: ORMP, “Oramed”) in September 2023.
  • For more information on Scilex Holding Company, refer to www.scilexholding.com .
  • For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com .

Silo Pharma Files Patent for Groundbreaking Ketamine Implant Therapeutic to Target Fibromyalgia and Chronic Pain

Retrieved on: 
Monday, March 18, 2024

SARASOTA, FL, March 18, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced that it has filed a provisional patent application titled ‘Methods and Combinations for Managing Pain’ with the United States Patent and Trademark Office (USPTO).

Key Points: 
  • The patent application includes protection for the Company’s SP-26 implantable drug delivery system for a novel time-released, dose-controlled formulation of ketamine, initially targeted for fibromyalgia.
  • Silo believes that implantable drug delivery may be well-suited for chronic pain management.
  • “Our SP-26 implant technology is designed to deliver a steady, low dose of ketamine for sustained relief of chronic pain,” said Eric Weisblum, CEO of Silo.
  • If approved, SP-26 could be the first at-home approved ketamine based therapeutic.”
    The next tests of the SP-26 ketamine implant will measure drug dissolution and time-release action.

Scilex Holding Company Provides Responses to Product Composition Questions Related to its ELYXYB® Patent in Canada for a New Drug Submission Under Review by Health Canada for the Approval of ELYXYB® for Acute Treatment of Migraine With or Without Aura in

Retrieved on: 
Monday, March 18, 2024

ELYXYB® (celecoxib oral solution) is in the same class of agents, is fast acting, and has the potential to have the lowest gastrointestinal (GI) side effects of all NSAIDs.3

Key Points: 
  • ELYXYB® (celecoxib oral solution) is in the same class of agents, is fast acting, and has the potential to have the lowest gastrointestinal (GI) side effects of all NSAIDs.3
    The anticipated timeline for approval in Canada is approximately 12 months depending on review cycles and information requests by Health Canada.
  • ELYXYB®’s product profile mapped with a high degree of certainty to these stated unmet needs.
  • For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com .
  • For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com .

Scilex Holding Announces Issuance of Halal Certification for its ZTlido® product by Circle H International, Inc.

Retrieved on: 
Friday, March 15, 2024

The certification is an important prerequisite for health care and covers health and wellness as well as non-addictive pain management products.

Key Points: 
  • The certification is an important prerequisite for health care and covers health and wellness as well as non-addictive pain management products.
  • The Halal certification was issued under the authority of Circle H International, Inc. (“Circle H”) and offers the Company the opportunity to provide ZTlido to Islamic markets globally.
  • Circle H issued the Halal Certification based on the global standards promulgated by its esteemed Circle H Sharia Advisory Council (the “Council”).
  • Circle H and the Council are recognized and supported by prominent governmental and non-governmental organizations and Islamic universities.