Opportunity
Established at the top of New Zealand sport. Entering the U.S. now, with a clinical pathway to reimbursement.
OptiRTP has developed Optimum Bio Sound Therapy (OBST), an FDA registered Class I medical device that delivers a precise, patterned acoustic signal through the auditory pathway.
It has been in real-world use since 2021, with 352,000+ documented therapy hours and zero serious adverse events on record. Non-invasive, measurable, and built to scale.
Documented therapy hours
Serious adverse events on record
New Zealand high-performance representatives supported
FDA registered Class I (510(k)-exempt)
2026 SelectUSA Investment Summit pitch competition
The problem
Chronic pain rarely stays in one place. It fragments sleep, pushes the autonomic nervous system out of balance, and compounds fatigue and stress - a burden carried by large patient populations and the health systems behind them. The tools meant to manage it force a trade-off: pharmaceutical options can carry dependence and tolerance risk and can lose effect over time, while non-pharmacological alternatives are either clinically validated but hard to scale, or scalable but unvalidated. What is missing is a measurable, non-invasive option that can scale.
The solution
Optimum Bio Sound Therapy (OBST) works through the body's own conduction system. A precisely patterned mechanical input enters through the ear, and the eardrum and cochlea convert it into neural signal along cranial nerve VIII - with a proposed mechanism involving brainstem circuits that regulate sleep, pain, recovery and stress. No drugs, no electrical current, nothing through the skin.
FDA registered Class I medical device since 2021 (establishment #3021235806); 510(k)-exempt under current classification. Registered with Medsafe in New Zealand.
Measured - documented therapy hours, a clean serious-adverse-event record, and observed movement in paired heart-rate variability (HRV) and resting heart rate (RHR), which is how we track the proposed autonomic effect. Reported - user experience, not converted into product claims. Hypothesized - the device effect itself, which the planned independent study is designed to test.
Through earbuds via a purpose-built app on a pre-configured, centrally managed tablet. We are improving the app and moving to custom (OEM) earbuds so delivery becomes more automated and far less hands-on. A one-to-many broadcast system is also in development, intended to unlock delivery at scale.
Our track record in sport
OptiRTP's foundation is high-performance sport. Over 352,000 documented therapy hours that include 76 New Zealand high-performance representatives - including Olympians, Paralympians, and national-team captains and coaches - and zero serious adverse events reported. Recovery gains have been observed on athletes' own wearables (observational and user-reported; individual results vary; not claims of medical efficacy). That foundation - results, trust and referral - is what is now opening doors across U.S. professional sport.
U.S. momentum
U.S. access is already underway, on the strength of the sport results:
- Third place in the pitch competition at the 2026 SelectUSA Investment Summit (Maryland) - the first New Zealand company selected to pitch in, and place in, that competition.
- Publicly recognised by the U.S. Embassy in New Zealand: Click here to read the article.
- Engagement with U.S. government agencies and their partners - the U.S. Commercial Service, the U.S. Consulate and Embassy, and AmCham New Zealand.
- Invited by Plug and Play to exhibit at its Frisco (Dallas-Fort Worth) sports-technology expo on 20 October 2026, supported by the Dallas Regional Chamber with a week of meetings across the region.
The pathway
Today - Class I foundation. Registered, in real-world use, and deployable under current registration; commercial in New Zealand sport and the basis for U.S. commercial entry now.
Near term - independent validation. Securing an independent pilot study, run by a third party rather than by us - the external validation the market wants us to secure.
Evidence - the study that matters. An independent clinical study on sleep and pain (sleep disturbance associated with chronic pain, with pain also measured), which would support the planned FDA De Novo reclassification to Class II.
FDA - potential De Novo Class II (in preparation, not filed or cleared). Creating a new device category rather than competing inside an existing one.
Reimbursement - the value inflection. The point at which a public payer, rather than the individual, pays for the therapy. This opens large U.S. channels - Veterans Affairs (VA), which runs healthcare for U.S. military veterans with more than 2.1 million already receiving care by video into their homes, and Medicare - and potential co-therapy applications being explored with pharmaceutical companies - whether OBST could help patients better tolerate demanding drug regimens, starting with chemotherapy. These channels are future opportunities, contingent on successful independent validation and FDA authorisation.
Platform - one-to-many expansion. A broadcast delivery system in development, plus additional channels (clinics, recovery programs, veteran health, and team/employer) as evidence and authorisation permit.
Market scale (reference)
Indicative third-party market sizes for the streams we are sequencing. These are market or public-payer scale only - not our customers, revenue or forecasts.
Sources: sports medicine, global market US$7.9bn (2025, Grand View Research); VA medical care, US$165bn (FY2026 VA budget); cancer supportive care, global market ~US$22bn (2025). Medicare, the U.S. federal health programme for people aged 65+, is ~US$1.2 trillion a year - the scale of the reimbursement opportunity, not a near-term market.
Where the enterprise value is created
The opportunity is not only today's device - it is the enterprise value created by category creation (a potential FDA De Novo classification) and a validated, scalable platform across high-performance sport, potential reimbursed-healthcare channels (VA and Medicare), and pharma co-therapy.
Request investor information
OptiRTP is engaging qualified investors. The financial model, projections, terms and capital structure are provided under NDA, after the required disclosures.
Request more information → CLICK FOR NDA AND FMCA WAIVERThe device is FDA registered (Class I, 510(k)-exempt) - not FDA-approved or cleared; any future FDA De Novo reclassification is in preparation, not filed or cleared. Cohort outcomes are observational and user-reported; individual results vary and are not claims of medical efficacy. Market-size figures are third-party reference points indicating market or public-payer scale only - not customers, revenue or forecasts. References to U.S. government agencies, events and introductions describe engagement or completed results, not endorsement or partnership. Forward-looking statements reflect current intentions and expectations, not commitments or assured outcomes. This page is a summary and is not an offer of securities; any investment is made only on the basis of the relevant FMCA disclosure statement and your own independent advice.
