At Akeeko, we're driven by a key question: "What if?"
What if patients receive treatment sooner? What if clinicians have tools that simplify workflow and increase procedural efficiency? What if wait times and resource burden on healthcare systems could be reduced?
The development of the Akeeko Stent Inserter™ started with a “what if” and is becoming a reality through close collaboration between surgeons, engineers, researchers, and commercialisation specialists. These leaders in their fields are united by Akeeko’s goal to transform standard care pathways to benefit patients, clinicians, and healthcare systems.
In this edition of Akeeko Advantage, we meet the people behind the innovation. This is a celebration of Akeeko’s in-house team and dedicated advisors, whose experience and commitment continue to underpin our journey from concept to commercialisation.
We also cover a significant chapter for Akeeko, including our FDA 510(k) submission and an oversubscribed AUD$8 million capital raise. See recent updates below.
Scientific Advisory Board
The development of the Akeeko Stent Inserter is grounded in clinical reality, shaped directly by surgeons who have lived these workflows for decades. Our Scientific Advisory Board brings together nine urologists from leading US institutions, each chosen for a different perspective.
Some help set the standard of care. Prof. Nicole Miller (Vanderbilt University) served on the American Urological Association panel that wrote the US guidelines for stone surgery. Prof. Khurshid Ghani (University of Michigan) leads a statewide collaborative that improves how kidney stones are treated across Michigan, and led a multi-centre trial on avoiding unnecessary stents after surgery. A/Prof. Michael Lipkin oversees clinical operations at Duke Urology, home to one of the few US programs specialising in complex kidney stones, and is a co-investigator on NIH-funded stone research.
Others are innovators and educators. Prof. Tom Chi, Chair of Urology at the University of Alabama at Birmingham, established the first x-ray-free kidney stone treatment centre in the US. A/Prof. Karen Stern directs Mayo Clinic Arizona's endourology fellowship, and Dr Rob Medairos (Duke University) has studied how new devices affect clinic capacity.
Not only are we well represented in leading academic centres, but our board also includes clinicians with influential roles in public and private hospital departments and busy large urology group practices, where decisions to adopt new devices are made. Dr Philip May chairs the Department of Surgery at EvergreenHealth, Dr Khanh Pham leads Overlake Clinics – Urology, and Dr Shawn Marhamati leads new devices and innovation at Potomac Urology, a member of the Large Urology Group Practice Association (LUGPA). Dr May and Dr Marhamati both trained at Melbourne’s Austin Hospital.
“This is exciting technology that fills a real need and solves a pain point for surgeons and patients - lack of access to the operating room. Being able to place a stent without needing to go to the operating room can really expedite care.”
- A/Prof. Michael Lipkin - Akeeko Medical Scientific Advisory Board
Business Advisory Board
Bringing an innovative device to market takes more than a good clinical idea and great engineering; it needs a sensible, well-thought-out commercial strategy. At Akeeko, we're fortunate to be guided by our Business Advisory Board, a team of industry experts. Many clinician- and engineer-led ventures discover that commercialisation is where the hardest lessons lie. Our business advisors help us get it right, providing practical insights and strategic advice as we prepare for domestic and international markets, drawing on decades of experience across capital raising, hospital procurement, market access and regulatory pathways.
Members include James Leech, former CBO of Palette Life Sciences (exited at US$600M) and currently Chief Financial & Strategy Officer at GT Medical Technologies; Nick Peace, a health tech commercialisation specialist and former Chief Strategy Officer at Pro Medicus, with more than US$1 billion in exits to his name; David Baker, central to the successful introduction of Barrigel and UroLift to ANZ; Bill Ranken, formerly Goldman Sachs JBWere, who brings significant financial and investment experience; and Prof. Damien Bolton (Austin Hospital, Melbourne, Australia) whose involvement ensures that our commercial strategy is backed by strong clinical evidence. Prof. Bolton and Bill Ranken are also investors in Akeeko Medical.
“The benefit from the Akeeko Stent Inserter is immediately apparent. It is a rare opportunity to be able to improve patient care by this magnitude.” - Dr Damien Bolton - Akeeko Medical Business Advisory Board
Team Akeeko
Akeeko Medical is led by Dr Joseph Ischia (Co-Founder & CEO), a practising urologist whose 15 years managing acute renal colic led him to conceive the Akeeko Stent Inserter. Don Fry AO (Co-Founder & Chief Engineer), one of Australia's Top 100 Most Influential Engineers¹, drew on six decades of engineering experience, including in medical devices, to turn Joseph's idea into a working prototype. Cyril Dixon (COO) brings two decades of operational leadership from senior roles at Movember and Ovarian Cancer Australia, and Ivan Mellado (Executive Chair) contributes 25 years commercialising deeptech, as a business development and marketing leader, director, investor and corporate advisor to early-stage ventures.
This leadership is backed by specialists putting the strategy into practice: Cara Webb (Clinical Trials Manager), a nurse consultant and trials coordinator with 20+ years' urology experience; Dr Oneel Patel (R&D Manager), with two decades in research across academia and industry; Olivia Passmore (GM, External Affairs), who has built and managed strategic relationships across investors, advisors, government and boards, and secured millions in philanthropic, private and government funding; and Rob Fletcher (Program Manager) and Abhijeet Kale (Quality Associate), bringing specialist expertise in manufacturing systems and TGA/FDA/EMA-regulated quality compliance respectively.
¹Engineers Australia Recognition: Named in the Top 100 list in 2006, and inducted into the Queensland Division Hall of Fame.
Recent Updates
REGULATORY: FDA 510(k) SUBMITTED
In September, Akeeko submitted its 510(k) application to the FDA for the Akeeko Stent Inserter. This follows the pre-submission meetings with FDA personnel including on the appropriate predicate device. The Submission was prepared with our regulatory counsel, Hogan Lovells, and is a key step on the path to commercial launch.
QUALITY: ISO 13485 AND MDSAP CERTIFICATION
In August, Akeeko Medical achieved ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) certification. This confirms our quality management system has been audited to and found to conform with ISO 13485:2016, including Australian and US requirements. MDSAP is recognised by both the TGA and the FDA, so this certification supports our regulatory applications in Australia and the US.
CLINICAL: REAL-WORLD USAGE
As at 13 October 2026, the Akeeko Stent Inserter has been used in 42 successful bedside procedures under the TGA Authorised Prescriber Scheme*, with zero adverse events. The time from referral to stent insertion is typically under 70 minutes, compared with around 16 hours under the current standard of care.
* The TGA Authorised Prescriber Scheme allows an Australian-registered medical practitioner to prescribe an unapproved medical device or medicine to specified patients with an unmet clinical need, without requiring individual approval from the TGA for each patient.
COMMERCIAL: FIRST REVENUE & NZ DISTRIBUTION
Akeeko has recorded its first commercial revenue, from hospital purchases of the Akeeko Stent Inserter under the TGA Authorised Prescriber Scheme. Importantly, these sales are an early sign of hospital demand ahead of formal clearance.
We are finalising a distribution agreement with a New Zealand distributor, with execution expected in the coming weeks. This will position New Zealand as our first market outside Australia, with supply to commence following regulatory notification.
CAPITAL: OVERSUBSCRIBED SHARE PLACEMENT
Akeeko completed a heavily oversubscribed AUD$8 million placement in September, managed by Morgans Financial. We thank our new and existing shareholders for their support, and the Morgans team for a highly efficient and effective process. The funding will enable Akeeko to complete regulatory clearances in the US and Australia, grow its team and move into commercialisation, with an initial focus on Australia and New Zealand.
Upcoming Activities
FDA AND TGA CLEARANCE
With our FDA submission lodged, the focus now shifts to review and response. Over the coming months, we will work with the FDA to address any questions and provide any additional information requested during its review of the 510(k) application. Following FDA 510(k) clearance, we will lodge the Akeeko Stent Inserter for inclusion on the Australian Register of Therapeutic Goods (ARTG).
We are targeting clearance from both regulators by Q2 2027.
CONFERENCES
Urological Research Society (URS) 2026 Meeting
Freiburg, Germany | October 8-10
Dr Joseph Ischia attended the URS 2026 meeting in Freiburg, Germany, joining leading researchers and clinicians in urology for the annual scientific symposium. Dr Ischia serves on the URS Executive Committee alongside a distinguished international board of urology researchers and academics. His standing in the global urology community, and the relationships formed at meetings like this, are an important asset as Akeeko looks to international markets.
In Closing
What began as an idea to solve a common problem experienced in hospitals across the globe is now approaching commercial launch. This progress has only been possible because of the breadth of knowledge and depth of expertise across our clinical, engineering and commercial team and advisors.
Most importantly, our shared commitment to solving real-world challenges for patients, clinicians and healthcare systems continues to drive us forward.
Thank you for your ongoing support.
