Tele: 561.316.3330
Breaking Medical Device News

Monday, October 18, 2021
HomeTITAN MEDICAL INC.Titan Medical Completes Survival Phase of GLP Chronic Procedures with its...

Titan Medical Completes Survival Phase of GLP Chronic Procedures with its Single-Port Robotic Surgical System

Today Titan Medical Inc. announced the successful completion of the chronic procedures performed under Good Laboratory Practice (“GLP”) principles using its single-port robotic surgery system, noting that all animals survived through the follow-up period. Ricardo Estape, M.D., a robotic gynecologic oncology surgeon specializing in robotic single incision surgeries from South Miami Gynecology Oncology Group, led the completion of the GLP studies.

The Company now intends to complete the full GLP studies report and required Summative Human Factors studies, followed by the full Human Factors Evaluation (“HFE”) report to facilitate filing of the Investigational Device Exemption (“IDE”) submission by the end of September.

“We are pleased to have successfully completed the survival phase of the chronic studies performed under the expert guidance of Dr. Estape for our IDE application to the U.S. Food and Drug Administration (“FDA”),” said David McNally, Titan’s chief executive officer. “All of the chronic study animals survived the required time following benign hysterectomy procedures using our single-port robotic surgery system. The demonstration of multi-week survival is a significant achievement for Titan. We are encouraged by the results and our team is now focused on completing the remaining milestones to support a 510(k) filing by year-end 2019.”

Dr. Estape said, “It was a privilege to lead these important studies with Titan’s single-port robotic surgery system and I am pleased that the post-surgery period has elapsed without complications. The survival of the chronic animals, along with the successful completion of other GLP acute animal and cadaver studies, demonstrates that I was able to complete the essential surgical tasks to achieve the desired results using the system. I remain very excited about the potential of Titan’s single-port robotic surgical system. Once cleared for clinical use, it may deliver single-incision surgery performance that could result in reduced trauma and faster healing for my patients.”

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected


Don't Miss

Adam S. Epstein New CEO of AliMed, Inc.

In his prior role as Chief Commercial Officer, Epstein directed all customer-facing, demand generation and product development activities. Under his new leadership, AliMed will continue to build a robust portfolio of contracted positions with major, national GPO’s, IDN’s, and Distribution partners to drive sales growth.

Tony Collins Appointed CFO of Xenter

“Xenter is building a platform for medical innovations that is transformational. The only way we can achieve our objectives is if we have great leaders like Tony Collins leading our company,” stated Richard J. Linder, Founder, Chairman & CEO of Xenter, Inc. “Tony brings incredible depth and experience to his new role as Chief Financial Officer.

HistoSonics Receives FDA “Breakthrough Device Designation” for Novel Sonic Beam Therapy

Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat.

Scott Sexton Appointed President at FIGUR8

"Scott brings to FIGUR8 30 years of workers' compensation, casualty, disability, and commercial health experience, most recently serving as a market leader for CorVel's national carrier practice sales team," said Nan-Wei Gong, CEO, and co-founder of FIGUR8.

Endolumik Inc. of Morgantown Secures $175,000 Angel Investment from Country Roads Angel Network

Endolumik, Inc. was founded in May 2020 by Mara McFadden, chief executive officer, and Dr. Nova Szoka, inventor of the surgical device.

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced...

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

By using this website you agree to accept Medical Device News Magazine Privacy Policy