Citric acid

Evofem Biosciences to Decrease Cost of Goods 45 Percent Through New Partnership with Bora Pharmaceutical Services for the Commercial Manufacturing of Phexxi®

Retrieved on: 
Tuesday, May 10, 2022

"We conducted a comprehensive evaluation of CMOs worldwide for the best manufacturing fit for Evofem and Phexxi.

Key Points: 
  • "We conducted a comprehensive evaluation of CMOs worldwide for the best manufacturing fit for Evofem and Phexxi.
  • Evofem has initiated technical transfer activities, and Bora is expected to begin manufacturing Phexxi in the fourth quarter of 2022.
  • Initially, Bora will manufacture Phexxi for nations currently considering formal regulatory approval of Phexxi for the prevention of pregnancy, including Mexico and Nigeria.
  • Bora owns and operates multiple cGMP manufacturing facilities in Asia and North America offering services for clinical and commercial manufacturing, packaging, and analytical testing.

The 2022 Society for Biomaterials, Technology Innovation and Development Award goes to Dr. Guillermo Ameer and the Acuitive Technologies Team

Retrieved on: 
Monday, May 9, 2022

ALLENDALE, N.J., May 9, 2022 /PRNewswire/ -- It all started with a vision by Northwestern's Dr. Guillermo A. Ameer, Daniel Hale Williams Professor of Biomedical Engineering at the McCormick School of Engineering and Surgery at the Feinberg School of Medicine, who has been awarded the  2022 Technology Innovation and Development Award by the Society for Biomaterials. 

Key Points: 
  • Acuitive Technologies has received 3 FDA Product Clearances for orthopedic devices (Citrelockfixation device, Citrefixsuture anchor and CitrelockACL).
  • The Citrelockfixation device was commercially launched in September 2021 with additional products to be commercialized in Q3 2022.
  • Acuitive also has several innovative Citregenbased products being readied for the market: Citreporesynthetic graft, Citresetsettable biologic adhesive and Citrebridgerotator cuff scaffold.
  • Ameer has co-authored numerous publications in high-impact journals, book chapters, patents, and conference proceedings and has received several awards for his research."

Gelesis to Report First Quarter 2022 Financial Results on May 12, 2022

Retrieved on: 
Monday, May 9, 2022

Gelesis (NYSE: GLS), the maker of Plenity for weight management, today announced that the Company will report financial results for the First Quarter ended March 31, 2022, on May 12, 2022 following the market close.

Key Points: 
  • Gelesis (NYSE: GLS), the maker of Plenity for weight management, today announced that the Company will report financial results for the First Quarter ended March 31, 2022, on May 12, 2022 following the market close.
  • The live conference call webcast can be accessed on the Gelesis Investor Relations website at https://ir.gelesis.com/ .
  • Gelesis Holdings Inc. (NYSE: GLS) (Gelesis) is a consumer-centered biotherapeutics company and the maker of Plenity, which is inspired by nature and FDA cleared to aid in weight management.
  • These filings address other important risks and uncertainties that could cause actual results and events to differ materially from those contained in the forward-looking statements.

Suneva Medical Inc. Announces Multiple Regulatory Approvals in the U.S. and Canada

Retrieved on: 
Tuesday, May 3, 2022

SAN DIEGO, May 3, 2022 /PRNewswire/ -- Suneva Medical, Inc. ("Suneva" or the "Company"), an innovative medical technology company using regenerative medicine to change the standard of care in aesthetic treatments, and partner Bimini Health Tech ("Bimini"), today announced that they have received approval from Canada's Medical Devices Directorate to market the Dermapose® all-in-one fat sizing syringe in Canada. In the U.S., Suneva has also received an additional 510(K) clearance from  the U.S. Food and Drug Administration (FDA) for its larger volume 30 mL Amplifine PRP gel tube.

Key Points: 
  • Suneva has also received U.S. FDA 510(k) clearance for a larger volume 30 mL gel tube.
  • "These domestic and international regulatory approvals display the growing number of regenerative aesthetic treatment options, and Suneva is proud to add to those options," said Pat Altavilla, Chief Executive Officer of Suneva.
  • On January 12, 2022 , Suneva Medical and Viveon Health Acquisition Corp. (NYSE American: VHAQ) ("Viveon Health" or "VHAQ"), a special purpose acquisition company, announced that they entered into a definitive merger agreement.
  • Bimini Health Tech is a global leader in the medical aesthetics and regenerative market.

Fig, the food as medicine company, officially launches its revolutionary mobile app, opening a new world of food opportunity for those with dietary restrictions.

Retrieved on: 
Monday, May 2, 2022

SAN DIEGO, May 2, 2022 /PRNewswire/ -- The Fig app, the most comprehensive food scanner and discovery app available, officially launches today, offering simpler and more well-informed grocery trips to the estimated 40-60% of Americans living with dietary restrictions. It marks an important step on Fig's journey to enable "food as medicine" everywhere – helping everyone feel their best through food.

Key Points: 
  • It marks an important step on Fig's journey to enable "food as medicine" everywhere helping everyone feel their best through food.
  • Co-Founders Max Rebarber and Andrew Hollar envisioned a world where it didn't take hours to find the food that fits all your needs.
  • I can relate from 2014 to 2017, I sought help for my severe GI symptoms from more than 20 doctors.
  • Fig is a venture-backed technology company created by a group of people with dietary restrictions, passionate about helping everyone feel their best through food.

Evofem Improves Phexxi® Patient Experiences Through New Agreement with VitaCare Prescription Services

Retrieved on: 
Wednesday, April 27, 2022

"This new agreement with VitaCare significantly streamlines access to Phexxi, which we anticipate will lead to more patients filling their Phexxi prescriptions," said Katherine Atkinson, Chief Commercial Officer, Evofem Biosciences.

Key Points: 
  • "This new agreement with VitaCare significantly streamlines access to Phexxi, which we anticipate will lead to more patients filling their Phexxi prescriptions," said Katherine Atkinson, Chief Commercial Officer, Evofem Biosciences.
  • "Our new collaboration with VitaCare is part of our ongoing efforts to find efficiencies in our business operations while offering our growing patient population comprehensive support.
  • Evofem is pleased to be working with the professionals at VitaCare and looks forward to integrating its programs for the benefit of Phexxi patients."
  • Evofem's agreement with VitaCare also supports the Phexxi sales force through VitaCare's expertise in managing any prior authorizations and other obstacles to a woman filling her Phexxi prescription.

Evofem to Present New Research in Gynecological Health at the 2022 American College of Obstetricians and Gynecologists Annual Meeting

Retrieved on: 
Tuesday, April 26, 2022

The Company's first FDA-approved product,Phexxi(lactic acid, citric acid, and potassium bitartrate), is ahormone-free, on-demand prescription contraceptive vaginal gel.

Key Points: 
  • The Company's first FDA-approved product,Phexxi(lactic acid, citric acid, and potassium bitartrate), is ahormone-free, on-demand prescription contraceptive vaginal gel.
  • It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex.
  • All forward-looking statements are expressly qualified in their entirety by such factors.
  • The Company does not undertake any duty to update any forward-looking statement except as required by law.

Evofem Biosciences to Report First Quarter 2022 Results and Provide Corporate Update on Wednesday, May 4, 2022

Retrieved on: 
Monday, April 25, 2022

SAN DIEGO, April 25, 2022 /PRNewswire/ -- Evofem Biosciences, Inc., (Nasdaq: EVFM) will hold a webcast and conference call to discuss financial results and business highlights for the first quarter ended March 31, 2022 as follows:

Key Points: 
  • Please connect to the webcast at least 15 minutes prior to the start of the call to download any software that may be required.
  • The Company's first FDA-approved product,Phexxi(lactic acid, citric acid and potassium bitartrate), is ahormone-free, on-demand prescription contraceptive vaginal gel.
  • It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex.
  • Phexxiis a registered trademark of Evofem Biosciences, Inc.

Virox™ Engineers a New Patented Disinfectant Technology with Enhanced Safety and Performance

Retrieved on: 
Thursday, April 21, 2022

Today, Virox announces its development of Citr-IQ, a new innovative patented disinfectant technology for professional use.

Key Points: 
  • Today, Virox announces its development of Citr-IQ, a new innovative patented disinfectant technology for professional use.
  • By harnessing the natural disinfectant power of citric acid, Citr-IQ maintains the balance of efficacy and safety that Virox antimicrobial technologies are known for while advancing performance in sustainability and material compatibility.
  • We are excited to be announcing our new patented technology and working to bring Citr-IQ to Infection Preventionists and their facilities."
  • Virox Technologies Inc. is a disruptive chemical engineering and disinfectant innovator who set a new standard in disinfection in 1998 with the patented technology, Accelerated Hydrogen Peroxide.

Billy Goat Brands’ Portfolio Company Evanesce Packaging Launches Sustainability-Themed Webinar

Retrieved on: 
Tuesday, April 19, 2022

The webinar, which includes a formal presentation as well as a recorded question and answer period at its end, can be accessed on: https://info.urban-expo.com/l/338151/2021-10-27/44s7xn

Key Points: 
  • The webinar, which includes a formal presentation as well as a recorded question and answer period at its end, can be accessed on: https://info.urban-expo.com/l/338151/2021-10-27/44s7xn
    Throughout the webinar, Mr. Horne addresses the concerns of using plastic packaging.
  • The two products include Evanesce PLA (PLA) and Evanesce Molded Starch (Molded Starch).
  • Billy Goat Brands is a venture capital platform focused on investing in high-potential companies operating in the ocean economy.
  • The paramount goal of Billy Goat Brands will be to generate maximum returns from its investments in a manner consistent with its environmental, social and governance values.