Surgery

LENSAR Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update

Retrieved on: 
Monday, March 4, 2024

“Our strong performance throughout 2023 continued in the fourth quarter, resulting in total revenue up 18% over the fourth quarter of 2022, with full-year revenue increasing 19%.

Key Points: 
  • “Our strong performance throughout 2023 continued in the fourth quarter, resulting in total revenue up 18% over the fourth quarter of 2022, with full-year revenue increasing 19%.
  • “Half of our 2023 ALLY installations were to new customers, and the vast majority of these ‘new’ LENSAR customers switched from competitive systems.
  • The increase from the fourth quarter of 2022 was primarily due to increases in ALLY System sales and procedure volume.
  • Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”) for the quarter ended December 31, 2023 was ($3.2) million, compared with ($1.8) million for the quarter ended December 31, 2022.

CMS Posts Final Medicare DMEPOS Fee Schedule Rate for the MyoPro®

Retrieved on: 
Friday, March 1, 2024

The final average fee schedule rates for the two Healthcare Common Procedures System (HCPCS) codes describing the MyoPro, L8701, our Motion W device, and L8702, our Motion G device, are $33,480.90 and $65,871.74, respectively, and can be found here beginning on page 67.

Key Points: 
  • The final average fee schedule rates for the two Healthcare Common Procedures System (HCPCS) codes describing the MyoPro, L8701, our Motion W device, and L8702, our Motion G device, are $33,480.90 and $65,871.74, respectively, and can be found here beginning on page 67.
  • On January 1, 2024, the MyoPro was officially classified in the brace benefit category, which enables reimbursement on a lump sum basis.
  • “This is an important milestone for qualified Medicare Part B beneficiaries with long-term muscular weakness or partial paralysis, and for Myomo as a company.
  • We extend thanks to the personnel at CMS for their efforts and for appreciating the benefits that powered braces such as the MyoPro can provide to Medicare Part B beneficiaries. "

LENSAR Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, March 1, 2024

LENSAR, Inc. (Nasdaq: LNSR) (“LENSAR” or “the Company”) today announced that a majority of the independent members of LENSAR’s board of directors granted seven newly-hired non-executive employees stock options to purchase an aggregate of 4,175 shares of the Company’s common stock.

Key Points: 
  • LENSAR, Inc. (Nasdaq: LNSR) (“LENSAR” or “the Company”) today announced that a majority of the independent members of LENSAR’s board of directors granted seven newly-hired non-executive employees stock options to purchase an aggregate of 4,175 shares of the Company’s common stock.
  • The options were granted as of March 1, 2024, as inducements material to each employee entering into employment with the Company.
  • The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The options are subject to the terms and conditions of LENSAR’s 2024 Employment Inducement Incentive Award Plan and a stock option agreement covering the grant.

Global Autologous Matrix-Induced Chondrogenesis (AMIC) Strategic Industry Report 2024: Market to Reach $278 Million by 2030 - Growing Demand for Minimally-Invasive Surgeries to Propel Market Growth - ResearchAndMarkets.com

Retrieved on: 
Thursday, February 29, 2024

The "Autologous Matrix-Induced Chondrogenesis (AMIC) - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Autologous Matrix-Induced Chondrogenesis (AMIC) - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.
  • The global market for Autologous Matrix-Induced Chondrogenesis (AMIC) estimated at US$153 Million in the year 2022, is projected to reach a revised size of US$278 Million by 2030, growing at a CAGR of 7.7% over the analysis period 2022-2030.
  • Collagen, one of the segments analyzed in the report, is projected to record a 7.5% CAGR and reach US$158.8 Million by the end of the analysis period.
  • The Autologous Matrix-Induced Chondrogenesis (AMIC) market is poised for growth due to the increasing prevalence of joint disorders.

Paragon 28 Reports Fourth Quarter and Full Year 2023 Financial Results and Provides 2024 Net Revenue Guidance

Retrieved on: 
Thursday, February 29, 2024

Consolidated net revenue for the fourth quarter of 2023 was $60.6 million, representing 17.6% and 17.3% reported and constant currency growth, respectively, compared to the fourth quarter of 2022.

Key Points: 
  • Consolidated net revenue for the fourth quarter of 2023 was $60.6 million, representing 17.6% and 17.3% reported and constant currency growth, respectively, compared to the fourth quarter of 2022.
  • Gross profit margin was 74.5% for the fourth quarter of 2023 compared to 81.5% in the fourth quarter of 2022.
  • Net loss was $19.6 million for the fourth quarter of 2023, compared to a net loss of $38.8 million for the fourth quarter of 2022.
  • Paragon 28 will host a conference call to discuss fourth quarter and full year 2023 financial results on Thursday, February 29, 2024, at 2:30 p.m. Mountain Time / 4:30 p.m. Eastern Time.

Endologix Initiates Percutaneous Transmural Arterial Bypass (PTAB)1 Post-Market Study

Retrieved on: 
Thursday, February 29, 2024

The study will leverage the Vascular Quality Initiative (VQI) registry infrastructure developed and supported by the Society for Vascular Surgery Patient Safety Organization (SVS PSO).

Key Points: 
  • The study will leverage the Vascular Quality Initiative (VQI) registry infrastructure developed and supported by the Society for Vascular Surgery Patient Safety Organization (SVS PSO).
  • The PTAB1 Post-Market Study evaluates the DETOUR System's performance in patients with very long (TASC D) SFA lesions.
  • The study plans to enroll up to 450 subjects, with a focus on including at least 200 women and also features an imaging sub study.
  • “The initiation of the PTAB1 Post-Market Study represents a pivotal moment in our ongoing commitment to advance the treatment of complex peripheral arterial disease.

HCA Healthcare, Inc. to Present at March Healthcare Conference

Retrieved on: 
Thursday, February 29, 2024

HCA Healthcare, Inc. (NYSE:HCA), is scheduled to present at the following healthcare conference:

Key Points: 
  • HCA Healthcare, Inc. (NYSE:HCA), is scheduled to present at the following healthcare conference:
    March 12, 2024 at 10:00 am ET at the 34th Oppenheimer Annual Virtual Healthcare Conference.
  • A link to the live audio webcast, where applicable, and copies of any related presentation materials will be made available at the Investor Relations section of the Company’s website, www.hcahealthcare.com .
  • Dates and times may be subject to change, please check the conference schedule or the Investor Relations section of the Company’s website for the latest information.

TriSalus Life Sciences Announces Real-World Data Demonstrating the Ability of TriNav® to Successfully Treat Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors

Retrieved on: 
Thursday, February 29, 2024

Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden.

Key Points: 
  • Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden.
  • In a matched cohort comparison, TriNav patients had fewer 30-day inpatient visits post-procedure than non-TriNav patients.
  • TriNav TARE patients with liver metastases had fewer clinical complications post-procedure vs. non-TriNav patients in a matched cohort comparison.
  • “This large sample size study underscores the particular benefits of the TriNav device compared to standard drug delivery systems.”

S.BIOMEDICS completes brain transplant of hESC-derived dopaminergic progenitors (TED-A9) for Phase 1/2a study in patients with Parkinson’s disease

Retrieved on: 
Thursday, February 29, 2024

S.BIOMEDICS Co., Ltd. (KOSDAQ: 304360) announced that it has successfully completed the brain transplant of TED-A9 (hESC-derived dopaminergic progenitors) for Phase 1/2a study for treating Parkinson's disease.

Key Points: 
  • S.BIOMEDICS Co., Ltd. (KOSDAQ: 304360) announced that it has successfully completed the brain transplant of TED-A9 (hESC-derived dopaminergic progenitors) for Phase 1/2a study for treating Parkinson's disease.
  • The primary objective of the Phase 1/2a trial is to assess the safety and exploratory efficacy of TED-A9 transplantation for two years post-transplant.
  • “We have developed a fundamental therapeutic mechanism that directly replaces dopaminergic neurons lost in patients with Parkinson's disease.
  • TED-A9 could represent a fundamental treatment that surpasses current therapies, which only temporarily alleviate the symptoms of Parkinson’s disease,” he added.

New Soldier® High Flow Microcatheter Granted FDA Clearance

Retrieved on: 
Thursday, February 29, 2024

Embolx Inc., a leading medical technology company developing microcatheters for arterial embolization procedures, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted clearance for the Soldier® High Flow Microcatheter, advancing localized drug delivery in vascular interventions.

Key Points: 
  • Embolx Inc., a leading medical technology company developing microcatheters for arterial embolization procedures, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted clearance for the Soldier® High Flow Microcatheter, advancing localized drug delivery in vascular interventions.
  • View the full release here: https://www.businesswire.com/news/home/20240229385059/en/
    Embolx Soldier High Flow Microcatheter - Received FDA Clearance (Photo: Business Wire)
    The Soldier microcatheter is a cutting-edge medical device created using the same Ultra-Thin Wall (UTW) technology and advanced design initially developed for its flagship product Sniper®.
  • With FDA clearance, Embolx introduces a new microcatheter platform technology that is now the basis for a pipeline of new products.
  • "The FDA clearance of the Soldier microcatheter represents a significant milestone in the evolution of advanced microcatheters.