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Healthcare

Amniowrap2™ Product Launch Leads Year of Highlights for BioStem Technologies

Amniowrap2™ Product Launch Leads Year of Highlights for BioStem Technologies

Jan 30, 2024

BioStem provides a business update and highlights recent accomplishments Preliminary fourth quarter net revenues of $11.5 million and full year 2023 net revenues of $16.7 million National Pricing for Amniowrap2™ effective January 1st in all 50 states and territories POMPANO BEACH, FLORIDA, January 30, 2024 - BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived allografts for advanced...

SS Innovations Announces Filing of Pre-Submission Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration

SS Innovations Announces Filing of Pre-Submission Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration

Jan 26, 2024

FORT LAUDERDALE, FL, January 26, 2024 - SS Innovations International, Inc. (the "Company" or "SS Innovations") (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that it has filed a pre-submission application with the U.S. Food and Drug Administration (FDA) requesting feedback on its SSi MantraTM Surgical Robotic System. SS Innovations received acknowledgement of this pre...

SS Innovations Announces Filing of Pre-Submission Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration

SS Innovations Partners with India’s Leading Medical Equipment Supplier, Medikabazaar

Jan 25, 2024

Collaboration to facilitate sales of the SSi Mantra Surgical Robotic System to hospitals and medical facilities across India FORT LAUDERDALE, FL, January 25, 2024 - SS Innovations International, Inc. (the "Company" or "SS Innovations") (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced it has entered into a partnership with India’s leading medical equipment supplier,...

Remsleep Holdings Inc.’s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

Remsleep Holdings Inc.’s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

Jan 22, 2024

Tampa, FL, January 22, 2024 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) has received a response to the company’s 510(K) submission K233415. The agency has determined that additional information is required. The agency has asked for additional information regarding Administrative Information, Device Description, Substantial Equivalence (SE), Labeling, Biocompatibility, and...

SS Innovations Announces Filing of Pre-Submission Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration

SS Innovations Launches Groundbreaking Inaugural Multi-Specialty Robotic Surgical Conference

Jan 22, 2024

SMRSC 2024 brings global medical experts and technological innovators together to explore the future of robotic surgery 13 Live, broadcasted surgeries were performed by distinguished multi-specialty surgeons, using the SSi Mantra Surgical Robotic System Distinguished guests included the Honorable Governor of Haryana, Mr. Bandaru Dattatreya FORT LAUDERDALE, FL, January 22, 2024 - SS Innovations International, Inc. (the "Company" or "SS Innovations") (OTC: SSII), a developer of innovative...

Oncocyte to Present at the Sequire Investor Summit in Puerto Rico

Oncocyte to Present at the Sequire Investor Summit in Puerto Rico

Jan 16, 2024

IRVINE, CA, January 16, 2024 - Oncocyte Corporation (NASDAQ: OCX), a precision diagnostics company, today announced that CEO Josh Riggs will be presenting a corporate overview at the upcoming Sequire Investor Summit 2024. The conference is scheduled for January 23-25, 2024 at the Condado Vanderbilt Hotel in San Juan, Puerto Rico. For more information about the Sequire Investor Summit, including registration details, please visit the official event website at https://puertorico.srax.com/ About...

Amniowrap2™ Product Launch Leads Year of Highlights for BioStem Technologies

BioStem Technologies Appoints Proven Life Science Sales Leader Shawn McCarrey to Chief Commercial Officer Role

Jan 11, 2024

Mr. McCarrey brings a strong track record of success and deep experience in regenerative medicine markets POMPANO BEACH, FLORIDA, January 11, 2024 - BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived biologics for advanced wound care, today announces it has appointed a proven life science sales leader, Mr. Shawn McCarrey, as Chief Commercial Officer. BioStem Technologies CEO, Jason...

SS Innovations Announces Filing of Pre-Submission Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration

SS Innovations Achieves Significant Milestones in 2023

Jan 8, 2024

Company’s award winning SSi Mantra surgical robotic system has completed over 550 surgeries and is clinically validated to perform more than 40 different types of surgical procedures Company Builds Strong Foundation for Future Growth FORT LAUDERDALE, FL, January 8, 2024 - SS Innovations International, Inc. (the "Company" or "SS Innovations") (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population,...

Microbot Medical is Set to Progress its Liberty Robotic System into Pivotal Clinical Trial; Shares soar 60%

Microbot Medical is Set to Progress its Liberty Robotic System into Pivotal Clinical Trial; Shares soar 60%

Dec 28, 2023

New York, December 28, 2023 - Microbot Medical Inc. (Nasdaq: MBOT) has completed its GLP pivotal pre-clinical study for the LIBERTY® Endovascular Robotic Surgical System. The study, adhering to FDA guidelines and using a porcine model, successfully met all its objectives, including conducting 96 robotic navigations by three interventional radiologists. This involved evaluating target vessels and surrounding tissues with the LIBERTY system controlling various intravascular catheterization...

SS Innovations Announces Filing of Pre-Submission Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration

SS Innovations Announces Strategic Partnership with Surgical Lab for Distribution in Africa

Dec 26, 2023

Pan African Medical Device Distributor Surgical Lab to place the SSi Mantra Surgical Robotic System in Healthcare Facilities across the African Continent Surgical Lab has Begun Registration of SSi Mantra in 27 African countries FORT LAUDERDALE, FL, December 26, 2023 - SS Innovations International, Inc. (the "Company" or "SS Innovations") (OTC:SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population,...

Lipella Pharmaceuticals Marks Successful First Year with Strategic Progress and Key Milestones Accomplished

Dec 20, 2023

-Lipella Granted Two Orphan Drug Designations by FDA- Pittsburgh, PA, December 20, 2023 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company") a pioneering, clinical-stage pharmaceutical company, celebrates its first anniversary as a publicly traded entity. Based in Pittsburgh, PA, the Company has made substantial strides over the past year, achieving critical milestones and advancing its pipeline with three clinical indications and two orphan drug designations...

PPJ Healthcare Enterprises, Inc. signed new Billing Accounts

PPJ Healthcare Enterprises, Inc. signed new Billing Accounts

Dec 19, 2023

TAMPA, FLORIDA, December 19, 2023 - PPJ Healthcare Enterprises Inc. (OTC Pink: PPJE) has announced today that it closed one billing agreement with a ‘pain management physicians’ group to provide their billing and collections. “We have been successful in providing specialty billing services for over 33 years, and we are very excited to add this group of physicians. The initial term of this agreement is two years. After taking time to sort out issues that held us back, the Company will now...

BioStem Technologies Appoints Executive Leader Patrick Daly to Board of Directors

BioStem Technologies Appoints Executive Leader Patrick Daly to Board of Directors

Dec 19, 2023

POMPANO BEACH, FLORIDA, December 19, 2023 - BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived biologics for advanced wound care, today announces it has appointed Mr. Patrick Daly to its Board of Directors. Mr. Daly is an award-winning executive leader with a strong track record of success in operations, strategy, sales, marketing, fundraising, and partnership-building. BioStem...

Center for Medicare Services Established National Pricing of AmnioWrap2 (TM) in All MAC Regions

Dec 14, 2023

Pricing Provides AmnioWrap2TM Reimbursement in All MAC Regions POMPANO BEACH, FLORIDA, December 14, 2023 - BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics for advanced wound care, announced that the Center for Medicare Services (CMS) has established national pricing for its product, AmnioWrap2TM, in all Medicare Administrative Contractors (MAC) regions. This pricing...

FDA Grants PMA Supplement Approval for ReShape Lifesciences Lap Band; Shares Surge 100%

FDA Grants PMA Supplement Approval for ReShape Lifesciences Lap Band; Shares Surge 100%

Dec 13, 2023

NEW YORK, NY, December 13, 2023 - ReShape Lifesciences (Nasdaq: RSLS) has been granted FDA approval of a PMA supplement for the company’s next generation, enhanced Lap-Band® 2.0 FLEX. The company’s share price surged 100% in trading on Wednesday morning. https://prismmarketview.com/companies/reshape-lifesciences-inc/ Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences, said, “PMA supplement approval for our next generation Lap-Band® 2.0 FLEX is a...

PRISM MarketView Biotech in Motion Spotlight: Quoin Receives FDA Clearance for Netherton Syndrome Clinical Optimization Plan

PRISM MarketView Biotech in Motion Spotlight: Quoin Receives FDA Clearance for Netherton Syndrome Clinical Optimization Plan

Dec 13, 2023

NEW YORK, NY, December 13, 2023 - Quoin Pharmaceuticals (Nasdaq: QNRX) has received U.S. Food and Drug Administration (FDA) clearance to implement several protocol amendments to its two ongoing clinical trials for QRX003, which is a potential treatment for Netherton Syndrome, a rare genetic skin disease for which there is no cure and no approved treatments. These protocol amendments are being implemented with a view to generating an even more robust data set and potentially more...

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

Dec 13, 2023

POMPANO BEACH, FLORIDA, December 13, 2023 - BioStem Technologies Inc. (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...

GK Financing LLC, a Subsidiary of American Shared Hospital Services, Announces Agreement to Reload Lovelace Medical Center with New Cobalt Sources and Software Upgrade

Dec 13, 2023

Installation expected to be Completed in Mid-2024 SAN FRANCISCO, December 13, 2023 - GK Financing LLC (GKF), a subsidiary of American Shared Hospital Services (NYSE American: AMS), a leading provider of creative financial and turnkey technology solutions for advanced radiosurgery and radiation oncology services, announced today that it has entered into an agreement with Lovelace Medical Center (LMC), Albuquerque, NM, to reload its Gamma Knife Icon with new Cobalt Sources, as well as install...

Hand-Spun Success: Why Did Shake Shack’s Shares Jump Today?

Hand-Spun Success: Why Did Shake Shack’s Shares Jump Today?

Dec 11, 2023

NEW YORK, NY, December 11, 2023 - Shares in the casual dining chain, Shake Shack ($SHAK) jumped nearly 10% today after the company provided a financial outlook for 2024 and announced the departure of its long-time CEO, Randy Garutti. Mr. Garutti will continue to lead Shake Shack as CEO and as an executive Board member until early 2024. The company stated it would retain Mr. Garutti as an advisor through the end of 2024 to ensure a seamless transition....

MyMD Tackles Rheumatoid Arthritis with Launch of Phase 2 Trial in Early 2024

MyMD Tackles Rheumatoid Arthritis with Launch of Phase 2 Trial in Early 2024

Dec 11, 2023

NEW YORK, NY, December 11, 2023 - The FDA has cleared an Investigational New Drug Application (IND) for MyMD Pharmaceuticals (Nasdaq: MYMD) to initiate a Phase 2 clinical trial of oral MYMD-1® as a treatment for rheumatoid arthritis (RA). The company plans to launch the trial in the first quarter of 2024. Chris Chapman, M.D., president, director, and chief medical officer of MyMD Pharmaceuticals, said, “With the FDA’s recent clearance of our IND in RA, we are moving forward with plans to...

Oncocyte Begins FDA Submissions Process for VitaGraft Transplant Assays

Dec 6, 2023

Significant unmet need for regulated product in $2B US testing market Opportunity for expedited pathway for kitted product in development IRVINE, CA, December 06, 2023 - Oncocyte Corporation (NASDAQ:OCX), a precision diagnostics company, today announced it has begun the FDA single-site process for its VitaGraft transplant assays. The single-site process is a well-established pathway for Lab Developed Tests (LDTs) to seek regulatory approval. This move positions Oncocyte within the recent...

Timber Pharmaceuticals Announces Commencement of NYSE American Delisting Proceedings: Common Stock Expected to Begin Trading on the OTC Market

Timber Pharmaceuticals Announces Commencement of NYSE American Delisting Proceedings: Common Stock Expected to Begin Trading on the OTC Market

Nov 29, 2023

WARREN, N.J., Nov. 29, 2023 -- Timber Pharmaceuticals, Inc. ("Timber" or the "Company") (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that the staff of NYSE Regulation (the “NYSE Regulation”) has determined to immediately suspend trading in the Company’s common stock from NYSE American, LLC (the “NYSE American”). As previously disclosed, the NYSE...

GK Financing LLC, a Subsidiary of American Shared Hospital Services, Announces Upgrading at Ecuador Center (GKCE) with State-of-the-Art Gamma Knife ICON

Nov 28, 2023

Upgrade of Gamma Knife® 4C with NEW Elekta ICON for most precise and accurate treatment of Intracranial cancers and other indications SAN FRANCISCO, Nov. 28, 2023 - GK Financing LLC (GKF), a subsidiary of American Shared Hospital Services (NYSE American: AMS), a leading provider of creative financial and turnkey technology solutions for advanced radiosurgery and radiation oncology services, announced today that it has demonstrated its continued commitment in Ecuador by completing the...

BioStem Technologies Reports Third Quarter 2023 Operating and Financial Results

BioStem Technologies Reports Third Quarter 2023 Operating and Financial Results

Nov 14, 2023

Company to Host a Conference Call and Webcast on November 14, 2023, at 10:30 am EDT POMPANO BEACH, FLORIDA, November 13, 2023 - BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics, today reported financial results for the quarter ended September 30, 2023. Jason Matuszewski, Chief Executive Officer of BioStem Technologies Inc. said, “2023 has been a remarkable year of growth...

Timber Pharmaceuticals Announces Commencement of NYSE American Delisting Proceedings: Common Stock Expected to Begin Trading on the OTC Market

Lipella Pharmaceuticals Granted FDA Orphan Designation for Oral Graft-versus-Host Disease Drug

Nov 10, 2023

“GvHD affects approximately 30,000 Americans and oral GvHD causes significant oral pain and discomfort, making it difficult for patients to eat, drink and speak. Oral GvHD is a great unmet need in cancer survivors.” Dr. Michael Chancellor, Chief Medical Officer at Lipella Pharmaceuticals Pittsburgh, PA, November 10, 2023 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our, “us” or the “Company”), has received Orphan Drug Designation for its LP-310 drug candidate for oral...

Oncocyte Reports Third Quarter 2023 Financial Results

Nov 9, 2023

-Launching First Products in 1H 2024- -Conference Call on Thursday, November 9, 2023, at 5:00 a.m. PT / 8:00 a.m. ET- IRVINE, CA, November 09, 2023 - Oncocyte Corporation (NASDAQ:OCX), a precision diagnostics company, today reported financial results for the third quarter of 2023, ended September 30, 2023. Third Quarter and Recent Highlights VitaGraft™ Kidney, the Company’s kidney transplant diagnostic test, received a positive coverage decision from CMS coverage; commercial revenue is...

BioStem Technologies Awarded Q Code for VENDAJE AC® Line from Centers for Medicare and Medicaid Services

BioStem Technologies Awarded Q Code for VENDAJE AC® Line from Centers for Medicare and Medicaid Services

Nov 8, 2023

POMPANO BEACH, FLORIDA, November 8, 2023 - BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture and commercialization of placental-derived biologics for advanced wound care, today announced that the Centers for Medicare and Medicaid Services (CMS) has published a new Q code, Q4279 for VENDAJE AC® pursuant to its application for Healthcare Common Procedure Coding System (HCPCS) “Q” codes. The HCPCS code assigned for VENDAJE...

BioStem Technologies Awarded Q Code for VENDAJE AC® Line from Centers for Medicare and Medicaid Services

BioStem Technologies to Report Third Quarter 2023 Financial Results on Tuesday, November 14, 2023

Nov 6, 2023

POMPANO BEACH, FLORIDA, November 6, 2023 - BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics for advanced wound care, announced today that it plans to release its third quarter 2023 financial results pre-market on Tuesday, November 14, 2023. BioStem will host a conference call and webcast at 10:30am ET on Tuesday, November 14, 2023. The call will include a discussion of...

BioStem Technologies Closes Oversubscribed $2M Private Placement

BioStem Technologies Closes Oversubscribed $2M Private Placement

Nov 3, 2023

POMPANO BEACH, FLORIDA, November 3, 2023 - BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics for advanced wound care, today announces that it has closed an oversubscribed private placement of common stock to accredited investors for an aggregate of 1,337,000 units (each, a “Unit”) at a price of $1.50 per Unit for gross proceeds of $2 million. Each Unit consists of one...

Oncocyte to Announce Third Quarter 2023 Financial Results

Nov 3, 2023

Conference Call and Webcast on Thursday, November 9, 2023, at 5:00 a.m. PT / 8:00 a.m. ET IRVINE, CA, November 3, 2023 - Oncocyte Corporation (NASDAQ:OCX), a precision diagnostics company, announced today that the company will host a conference call and webcast on Thursday, November 9, 2023, at 5:00 a.m. Pacific Time / 8:00 a.m. Eastern Time to discuss its third quarter financial results and recent highlights. The third quarter 2023 financial results press release will be issued the same day,...