Hornsby business hopes to jazz up orthopaedic surgery

By Brent Balinski

You may be familiar with various implants used to heal damaged bones – screws, rods, plates and other metal bits and pieces, ones fashioned from newer varieties of materials engineered to mimic what they replace, grafts from elsewhere on a patient’s body etcetera. 

Dr Maryam Parviz, a biomedical engineer and co-founder/CEO at SDIP Innovations, says that 60 per cent of surgeries still use a patient’s own bone due to a lack of optimally-performing synthetic options. 

When it comes to successfully filling gaps in damaged bones, there’s apparently a gap in the market. 

“There are ones that are purely ceramic – they’re good in terms of bone conversion. Because they provide the calcium, the phosphate, the food that bone needs for regeneration. What they don’t provide is the mechanical biocompatibility for the cells,” Parviz tells @AuManufacturing during a visit to the company’s Hornsby factory.

“So they don’t provide that structural integrity that cells need for an efficient bone conversion to create a quality new bone.” 

There are issues like brittleness for ceramic, too, she adds: smash it and “it turns to powder.”

Parviz’s company got started in 2018 to commercialise JAZBI, made of a mix of ceramic, polymer and carbohydrate materials. The porous material is designed to fill a void, encourage the growth of new bone, and safely dissolve into carbon dioxide and water.

Co-founder and Chief Scientific Officer Dr Iman Manavitehrani studied biodegradable implants for his PhD, before postdoctoral work at Westmead Children’s Hospital exposed him to the woes of children needing repeat surgeries after outgrowing implants, inspiring the development of what would become JAZBI.

According to the pair, it has the potential to save surgery time by 15 to 20 minutes and is better in many ways than other bioresorbable implants, which can create acidic byproducts as they degrade and lead to inflammation and other problems.

It can bend and support weight like bone, and its porosity and the rate it dissolves can be tailored for different surgeries. 

SDIP’s efforts have received support from the NSW Health Medical Devices Fund and the now-discontinued federal Accelerating Commercialisation program. Parviz and Manavitehrani were also awarded a two-year fellowship at the UC San Francisco Rosenman Institute and QB3 Incubator, before returning in 2022 and establishing a factory on Sydney’s Upper North Shore.

This year, the company was part of @AuManufacturing’s Australia’s 50 Most Innovative Manufacturers list.

The first product based on JAZBI is a selection of different filler shapes – including wedges, cubes and rods – with following planned releases including an applicator and cartridges (likened to a hot glue gun) and surgical screws and pins.

The first market being targeted is the US, where SDIP developed a network of contacts during the Bay Area years.

Parviz says of the first product: “We’ve done all the studies required for [the] FDA. We’re putting the technical file together to submit that for regulatory approval.”

As for when she expects JAZBI to make its way into a patient: “That should be next year, hopefully.”  

In this episode of @AuManufacturing Conversations, Parviz tells us about why better bone implants are needed, the road to commercialisation, why the company decided in-house production was the only way after considering contract manufacture, and more.

The episode is sponsored by ECI Software Solutions.

Episode guide

0:26 – What SDIP does – next-generation bioresobable bone implants – and Parviz’s professional background.

2:25 – Development of the implants by the company’s co-founder as an answer to repeat surgeries.

3:30 – The scholarship from NSW Health in partnership with QB3 incubator and the UCSF Rosenman incubator.

4:32 – What JAZBI is and does.

5:40 – 60 per cent of surgeons use bone from another part of the patient’s body, or from cadavers.

7:20 – Their product versus ceramics, which Parvis says are brittle rather than shapeable. Bone fillers created in granule, wedge and rod shape plus fillers (with rod-shaped cartridges) used in a delivery device.

9:26 – What it’s made of and how it’s made.

10:55 – The path to clinical acceptance. Hopefully in a patient next year.

12:40 – The business model. 

15:01 – What lure might’ve been attached to staying in the Bay Area and not returning to Sydney to establish the business and its products.

19:07 – Establishing the factory in Hornsby.

22:30 – Manufacturing process development while in the Bay Area and the value of this.

23:50 – Why the fundraising environment for medical device companies in Australia isn’t as mature as it could be, and what this means for new companies.

28:10 – The art of innovation in manufacturing and at SDIP.

30:20 – First sales will be in the US market.

31:15 – The skillsets involved, talent attraction at SDIP, and the challenging nature of this.