Previous projects

Over the space of more than 15 years, we have worked across numerous innovative, challenging, and unique projects. Below you can find several case studies showcasing some of the projects that we are most proud of, in addition to highlighting some of the notable milestones that we have achieved throughout our company’s history.

Aveta (Meditrina Inc.)

Product description

The Aveta System removes uterine fibroids, polyps and/or retained products of conception (RPOC) from the uterus with a minimally invasive hysteroscopic approach with no incisions. This simple and quick surgical procedure will allow the patients back on her feet and enjoying daily life activities within a few days. Hysteroscopic procedures are the preferred polyp and/or fibroid treatment for women who may want to still become pregnant.

Our role

As a contract developer and small-scale manufacturer we had an important role in the development of the handheld disposable hysteroscope and fluid management system, starting from the products’ first prototypes through a few iterations until the clinical study stage conducted at Semmelweis University in Budapest. Since the market approval of the system we are responsible for the commercial production of the disposable hysteroscope devices and a few key subassemblies of the controller. In our past we usually supported projects until commercial production. We are very proud that we could heavily increase our manufacturing output to be able to fulfill the rapidly rising market needs for Meditrina hysteroscopes.

Veloxion (Corinth MedTech)

Product description

The Veloxion System, featuring Velo360 Technology, is FDA cleared for use in treating the symptoms of benign prostatic hyperplasia (BPH), conditions affecting millions of people worldwide. Corinth and MedRes developed in cooperation the first-of-its-kind single-use resectoscope for TURP addressing unmet needs in an innovative and cost- effective manner.

Our role

We had the opportunity to act as a contract developer for the handheld disposable resectoscope and the fluid management system from the start of the project until the clinical study stage conducted at Semmelweis University in Budapest and University of Debrecen. During that timeframe we have manufactured approximately 1000 disposable resectoscope devices to support the validations and clinical trials. We had delivered many ideas and inventions that led to the current state of the resectoscope, especially in the design and manufacturing process development of the patented atraumatic tip.

Symphion (IoGyn Inc.)

Product description

The Symphion System is a next-generation surgical system designed for the hysteroscopic removal of fibroids (myomas) and polyps, combining bladeless resection (cut & coag) with intrauterine pressure-regulated saline circulation. This system aims to preserve a woman’s ability to have children by making the removal of symptomatic fibroids and polyps both safer and less invasive compared to common surgical approaches.

Our role

We played an imperative role in the development of the handheld device’s probe, controller and fluid management system. We were first engaged to develop the product’s first prototype and carried it through to its clinical study stage and production transfer. We were involved in the clinical studies conducted at Semmelweis University in Budapest, and manufactured approximately 1000 devices for testing and clinical trials.

We provided documentation for the regulatory approval process and FDA clearance was granted in less than eighteen months following the start of the project. After obtaining the FDA’s approval, IoGyn was acquired by Boston Scientific, thereby broadening their medical device portfolio.

iKnife (MediMass Ltd.)

Product description

iKnife is a special surgical device that, by using rapid evaporative ionization mass spectrometry (REIMS), identifies biological tissues during surgery. Using this technology provides real-time information which allows HCPs to deduce whether tissue contains cancer cells. Such information allows the operating surgeon to remove all cancer cells whilst reducing the damage caused to nearby healthy tissues, resulting in shorter and less expensive surgical procedures.

Our role

We offered robust engineering and prototyping support to the iKnife team. Within the first two weeks of the project, the first prototypes of the iKnife had been produced, and in line with MediMass’ request, 1000 iKnife blades of various types were manufactured for the purposes of examination and testing. MediMass’ innovative system was subsequently purchased by Waters Corporation, a company we continue to support in their design and testing of new device generations and variants, helping them to address evolving clinical and commercial needs.

Minerva EAS (Minerva Inc.)

Product description

Minerva EAS is a surgical system designed for the controlled ablation of the endometrium, the innermost layer of the uterus. The basic principle on which this technology operates is the ionization of argon gas which in turn facilitates the creation of plasma in the silicone membrane that is located at the distal tip of the device – this plasma energy is then used for ablation. The system is designed to concentrate energy to the least ablated area, thus providing a safer and a less invasive method for treatment, and a reduced number of patients requiring a full hysterectomy.

Our role

We played a key role in the development of the controller and handheld unit, with our involvement starting with the development of the first prototype and continuing throughout the final testing stages, manufacturing devices needed for initial tests and clinical studies. As part of this process, we supported the compilation of the required submission documentation in addition to supporting Minerva EAS in the subsequent steps necessary for obtaining FDA approval. We were also involved in the production of the device’s first generation and supported the manufacturing transfer process.

StabiliT (DFine Inc.)

Product description

The StabiliT system is used in the treatment of vertebrae that are weakened and fractured as a consequence of osteoporosis. The system stabilizes the injured vertebra by injecting high-viscosity bone cement, with increased precision attributable to the system’s articulating distal end. Following the operation, patients can achieve improved quality of life.

Our role

We were responsible for both the design and development of the handheld device and controller unit, as well as manufacturing process development. We manufactured one of the critical components of the system in our cleanroom. As part of our involvement, we contributed to the drafting of submission documentation and supported DFine Inc. in the US regulatory approval process. Following the FDA’s approval and the market launch, DFine Inc. was acquired by Merit Medical.

References