A Medical Device Daily

Symmetry Medical (Warsaw, Indiana), an independent provider of products to the global orthopedic device industry and other medical markets, reported a supply agreement with Mako Surgical (Hollywood, Florida), an orthopedic surgical solutions company.

Symmetry will supply Mako with future implants, instruments and associated products designed to be used in delivering Mako’s MAKOplasty therapy.

MAKOplasty is a surgical solution that is designed to enable orthopedic surgeons to reproducibly and precisely treat patient-specific early to mid stage osteoarthritic knee disease. MAKOplasty is performed using Mako’s FDA-cleared Haptic guidance system, a surgeon-interactive haptic robotic platform that uses patient-specific visualization to prepare the knee joint for insertion of Mako’s resurfacing implants through a keyhole, bone-preserving and tissue-sparing incision. MAKOplasty is designed for patients with early- to mid-stage osteoarthritic knee disease who desire a restoration of lifestyle, pain reduction and a rapid recovery, the company said.

“As Mako’s lead development and manufacturing provider, Symmetry will enhance Mako’s ability to bring its innovative technologies to the market more widely and rapidly, and enable the company to meet the growing demand for its systems,” said Brian Moore, president/CEO of Symmetry Medical. “This agreement keeps Symmetry Medical on the leading edge of the orthopedic industry, providing Mako and its customers with the assurance of the highest quality for the products surrounding its MAKOplasty program.”

As the primary supplier of all implants, instruments and products for Mako, Symmetry said it will incorporate its Total Solutions offering, an integrated service that encompasses all elements of the orthopedic supply chain, from design and development through final delivery, to ensure Mako with the highest quality products and prompt distribution channels.

Symmetry provides implants and related instruments and cases to the orthopedic device industry. The company also develops these products for companies in other segments of the device market, including arthroscopy, dental, laparoscopy, osteobiologic and endoscopy sectors and provides limited specialized products and services to non-healthcare markets, such as the aerospace market.

Mako Surgical is a privately held, emerging orthopedic device company.

In other agreements:

• Arrhythmia Research Technology (Fitchburg, Massachusetts) reported that its wholly owned subsidiary, Micron Products, has entered into a five-year supply agreement with ConforMIS (Lexington, Massachusetts). Micron, through its Micron Integrated Technologies and Leominster Tool divisions, will provide manufacturing services for the ConforMIS Knee Interpositional Device, the iForma, for use in the treatment of patients with early to moderate osteoarthritis.

ConforMIS develops patient-specific implants capable of re-establishing normal articular alignment and relieving pain in patients with osteoarthritis of the knee. Each device is made to conform to an individual patient’s unique anatomy, allowing for maximum tissue preservation and minimal surgical trauma.

The ConforMIS iForma is a small, lightweight, personalized metal implant designed for patients with early to moderate osteoarthritis in either the medial or lateral compartment of the knee. It fits into the affected compartment between the femur (thigh bone) and tibia (shin bone) and helps fill the lost cartilage, restore the knee’s proper alignment, and prevent painful rubbing of the bones during ambulation. Its precise fit to the structure of the joint allows the surgeon to easily insert the device through a small incision, achieving functional fixation without the need for cement or screws. The iForma allows patients to return to light to moderate physical activities and allows for easy revision to other procedures in the future, if necessary, according to the company.

• Ensemble Discovery (Cambridge, Massachusetts) reported the initiation of a collaboration with Roche (Basel, Switzerland) to apply Ensemble’s diagnostic technology to the optimization of selection of cancer therapy. The collaboration will apply this technology (known as DNA-Programmed Chemistry) to analyze combinations of members of the Epidermal Growth Factor Receptor (EGFR) family that are present in cancer tissues. The goal of the collaborative project is to create a sensitive test to detect receptor dimers in human cancer tissue samples, the company said.

The potential clinical benefit of the test is to select cancer patients who are most likely to respond to a particular therapy targeted against a member of the EGFR family. The particular combinations of EGFR dimers present in the cancer are believed to be a significant factor in determining the efficacy of drugs targeting the EGFR family.

The EGFR family includes some of the most widely targeted molecules in modern cancer medicine. There are six drugs against this family on the market and several more in clinical trials. However, in each case, the drugs show activity in a subset of the patients in which they are currently indicated and the mechanisms of this partial efficacy are not well understood.

Ensemble is developing a suite of diagnostic services and kits, based on DNA-Programmed Chemistry (DPC), to analyze EGFR family dimers and other cancer markers for use in cancer diagnosis and drug selection. The company said it will partner with leading pharmaceutical and diagnostic companies to deliver its diagnostic products and position them relative to ongoing drug development.