Freyja HealthCare’s VereSee™ Device Receives 510(k) Clearance, the First of Many Products
BOSTON, May 8, 2024 (Newswire.com) - Freyja Healthcare, an early-stage medical device company focused on developing a robust product portfolio of highly innovative products for women’s health, today announced that its novel VereSee device received 510(k) clearance from the United States Food and Drug Administration (FDA). Clearance from the FDA marks a critical step in enabling Freyja and VereSee — the first and only 2mm, safe abdominal-access video-entry device for laparoscopic surgery — to bring further innovation in the fast-growing women’s health market. VereSee will reinvigorate a category that has not seen innovation in over three decades.
Founded by Jón Ívar Einarsson, MD, PhD, MPH, and Gaby Moawad, MD, FACOG, Freyja’s mission is to raise the standard of women’s health in both surgical and in-office procedures, enabling physicians to deliver safe and effective care. As the company’s first novel product, the VereSee device features a proprietary design engineered to be simple for the surgeon, safe for the patient, and highly differentiated from the current standard of care. The company now has four products in advanced stages of development, 17 granted patents and 21 pending patents.
“From the beginning, I’ve been impressed with Freyja’s mission to improve gynecologic solutions for women and the providers who take care of them. With this first product, Freyja is bringing meaningful innovation to a category ready for change,” said Kim Rodriguez, longtime Freyja Executive Chairman and former CEO of Acessa Health.
There are 4.8 million laparoscopic surgeries performed annually in the United States. Abdominal entry is the most dangerous step of laparoscopic and robotic surgery in women’s health, and in all laparoscopic surgery across all specialty areas. This dangerous step results in one patient death and eight injuries in the U.S. each day[1].
“The standard of care is dangerous and outdated. Initial entry is often done blindly with Veres needles or a 5-12mm optical trocar,” said Jón Ívar Einarsson, MD, co-founder and interim CEO of Freyja. “Damaging the bowel or vasculature because of blind entry can cause significant harm, even death, if undetected.”
As a part of the FDA clearance process, Freyja performed extensive testing and documentation of the safety and efficacy of the product, validating the company’s confidence in the design of its VereSee product.
“FDA clearance has been a long process for us, and we know that this is one of the largest barriers to entry for new products in this category,” said Gaby Moawad, MD, co-founder and Board Director of Freyja. “However, we understand the importance of these devices being held to the highest standards of safety and quality. We are proud of the work our team has done to reach this milestone for Freyja.”
Freyja will soon begin initial commercialization of the VereSee device, with broad availability expected in the second half of 2024.
About Freyja Healthcare
Freyja Healthcare was founded in 2017, has four products in advanced stages of development, 17 granted patents and 21 pending patents, and is engineering a robust product portfolio focused on safe and effective surgical and in-office solutions for women. Founded by two well-respected, minimally invasive gynecologic surgeons, Jón Ívar Einarsson, MD, PhD, MPH, Past-President of AAGL, founder of the Division of Minimally Invasive Gynecologic Surgery (MIGS) at Brigham and Women’s Hospital (BWH) and a Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School, and Gaby Moawad, MD, FACOG, Associate Professor of Obstetrics and Gynecology at The George Washington University School of Medicine and Health Sciences (GWSMHS). Drs. Einarsson and Moawad are inventing and building the products they wish they had early in their careers and elevating the standards for products used in women’s health surgical and in-office care. Freyja has raised almost $8 million in seed funding from private and professional high net-worth investors. Learn more at Freyja Healthcare.
[1] Clark NV, Einarsson JI. Laparoscopic entry techniques. In: Minimally invasive surgery in gynecologic practice. De Gruyter 2020.
Contact Information:Jerry Brecher
info@freyjahealthcare.com
Original Source: Freyja HealthCare's VereSee™ Device Receives 510(k) Clearance, the First of Many Products
Clear Cannabis, Inc. Expands ‘The Clear’ Brand in New Jersey With Kushi Labs
DENVER, May 8, 2024 (Newswire.com) - In response to growing consumer demand, Clear Cannabis, Inc. (CCI), a leader in cannabis innovation and quality since 2013, is thrilled to announce the expansion of its popular brand, The CLEARTM to New Jersey through a strategic partnership with Kushi Labs. This collaboration marks a significant milestone as the company introduces its top-tier cannabis products to The Garden State. This marks the 12th state for The Clear and its market expansion.
Under this agreement, CCI will license its IP formulas, processes, and operational knowledge to Kushi Labs.
"The CLEAR has consistently set the benchmark for excellence and innovation in the cannabis market," said Richard M. Batenburg, Jr., CEO of Clear Cannabis, Inc. "Our decision to bring The CLEAR to New Jersey with Kushi Labs is a testament to our commitment to meet consumer demand and deliver unparalleled cannabis experiences."
The CLEAR's products are celebrated for their unparalleled purity, potency, and palate-pleasing flavors, setting the industry standard for cannabis product excellence.
This expansion into New Jersey is driven by a strong market demand and a commitment to making these superior products more accessible to discerning consumers in more states.
Kushi Labs, known in the New Jersey cannabis sector for its exceptional manufacturing processes, will serve as the licensed partner, ensuring that the same high-quality standards known across the U.S. are upheld. The CLEAR’s entry into New Jersey is anticipated to set new benchmarks in the market for product quality and consumer satisfaction.
"Our partnership with Clear Cannabis, Inc. represents a pivotal development in our mission to offer the best cannabis products to New Jersey residents," stated Ajay Patel, CEO of Kushi Labs. "The CLEAR’s reputation for quality and trust makes them the ideal partner for us as we look to elevate the cannabis experience in our state."
This expansion into New Jersey coincides with the Biden administration's recent announcement to reclassify marijuana as a class-3 drug, easing restrictions on its use and research.
“The reclassification of marijuana by the White House is a significant step towards greater acceptance and accessibility of cannabis products, and The CLEAR is proud to be at the forefront of this movement,” said Batenburg.
About The Clear Cannabis, Inc.:
Since its inception in 2013, The CLEAR (part of Clear Cannabis, Inc.) has been at the innovation forefront of the cannabis industry, offering a diverse range of products from vapes to edibles, pre-rolled joints and more. Known for its exceptional flavors and consistent quality, The CLEAR has become one of the most trusted and awarded cannabis brands in the United States.
From Mild to Wild and Everything Between, The CLEAR has something for everyone, catering to a wide array of lifestyles and preferences, ensuring a premium experience to be enjoyed by all.
For additional information about Clear Cannabis, Inc. and The CLEAR, please visit https://clearcannabisinc.com/.
About Kushi Labs:
Founded in 2021, Kushi Labs is a leading Licensed Cannabis Manufacturing facility in New Jersey. Dedicated to becoming the primary supplier for cultivators and dispensaries statewide, the company emphasizes innovation and excellence. By integrating advanced technology, Kushi Labs sets high standards in cannabis manufacturing quality and efficiency. Supported by a diverse team of engineers, scientists, businessmen, and connoisseurs, all united by their passion, Kushi Labs commits to delivering outstanding products and services as an industry leader.
Contact Information:Brett Schklar
CMO
b.schklar@clrcan.com
3038832449
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Original Source: Clear Cannabis, Inc. Expands 'The Clear' Brand in New Jersey With Kushi Labs
What’s Hot for Mother’s Day, Father’s Day, and Summer Barbecues
HILLSIDE, N.J., May 7, 2024 (Newswire.com) - Joseph Enterprises, Inc. announces The 'Ove' Glove as the perfect present for the upcoming gifting and grilling season for Mom, Dad and barbecue enthusiasts. The ‘Ove’ Glove is crafted from the same high-performance material trusted by firefighters, ensuring protection up to 540 degrees.
With over 20 million sold and endorsed by both Consumer Reports and Bon Appetit Magazine, The ‘Ove’ Glove has been hailed as the pinnacle of heat protection for 20 years and is now also available as a BBQ Glove.
Get your hands on the The ‘Ove’ Glove Hot Surface Handler Oven Mitt for a thoughtful Mother’s Day or Father’s Day gift, and make sure that all the barbecue lovers in your life have the The ‘Ove’ Glove BBQ Glove in their grilling tool set.
Whether in the kitchen or by the grill, with its three layers of flame-retardant material, silicon grips, and five-finger flexibility, The ‘Ove’ Glove allows for superior control while handling hot plates and grilling essentials without slippage.
The ‘Ove’ Glove is available at Amazon, ACE, Wegmans, Do It Best, True Value, and Walmart.com and in Canada at Canadian Tire, Home Hardware, London Drug Stores, and other fine stores. For more information on The ‘Ove’ Glove, go to www.oveglove.com.
Ensuring that your heat and flame hand protection gift is the original and only The ‘Ove’ Glove will mean unbeatable performance and peace of mind.
About The ‘Ove’ Glove
Joseph Enterprises, Inc. (JEI) is the home of the original ‘Ove’ Glove. JEI is an integrated consumer product company which designs, markets, and distributes novelty, home, and garden products. JEI rose to success with its two most popular products, the Chia Pet and The Clapper, which are recognized as consumer icons.
Contact Information:Jason Blake
pr@radicalshareww.com
Original Source: What's Hot for Mother’s Day, Father’s Day, and Summer Barbecues
Popular
Exclusive Screening of Highly Anticipated Film, ‘The Firing Squad,’ in Phoenix, AZ on May 28, 2024
NEW YORK, May 15, 2024 (Newswire.com) - On May 28, 2024, Epoch Studios is screening their first ever film, "The Firing Squad," in Phoenix, AZ. Select local faith and community leaders, as well as members of the media and other guests, will have the opportunity to preview the powerful story of redemption ahead of the nationwide release on August 2, 2024.
Based on a profound true story of finding hope in the face of death, celebrated Christian filmmaker Tim Chey’s “The Firing Squad” follows the story of three convicted criminals who were sentenced to be executed by firing squad in an Indonesian prison camp in 2015. As the countdown to their deaths begins, a remarkable sequence of events unfolds, which drew international attention to the transformative power of faith and hope that transcends our darkest moments.
"The Firing Squad" promises a thought-provoking cinematic experience, starring prominent actor Kevin Sorbo (“God’s Not Dead” and “Let There Be Light”) alongside breakout star James Barrington. Talent is available for Phoenix area interviews in conjunction with the May 28, 2024 screening. A trailer of the film is available for viewing at https://www.youtube.com/watch?v=PSsOE7WwsZ8.
“At its core, this film is a story of courage, resilience and the transformative power of salvation through Jesus Christ,” said Chey. “I’m an evangelist first and a filmmaker second. Beyond mere entertainment, I pray the film will serve as a catalyst for introspection, compelling audiences to embrace the grace and love of Jesus Christ.”
The creators of the film want to see it win 1 million souls to Christ.
Sorbo, a vocal advocate for family friendly entertainment, has emphasized the importance of supporting faith-based projects like The Firing Squad.
“In today’s entertainment landscape, it’s crucial that we rally behind projects that uphold Christian values and share stories of faith,” said Sorbo. “We have a battle to win in Hollywood. Films like this are powerful tools for spreading messages of hope and inspiration.”
For screening information visit: themoviescreener.com/thefiringsquad/main and for exclusive content, visit the official website: firingsquadfilm.com or follow the film on social media:
- Facebook: facebook.com/TheFiringSquadMovie
- X: twitter.com/FiringSquad2024
- Instagram: instagram.com/firingsquadfilm
- Linkedin: linkedin.com/showcase/firingsquad
- YouTube: youtube.com/channel/UCbzzOpAcpvwwrm24-cS1bCg
Chanel Turner
chanel@alarryross.com
(214) 240-6155
Original Source: Exclusive Screening of Highly Anticipated Film, 'The Firing Squad,' in Phoenix, AZ on May 28, 2024
