CONFIDENTIAL
Newsletter | Welcome to our second edition of The Root Matters.
Exciting Steps Forward in Knee Restoration
Investor team,
We should all be proud of the Native Ortho team and the years of work they have condensed into just 6 months since our last newsletter. We are accomplishing everything we were bullish on back in Q3 and Q4, including obtaining our first FDA 510K clearance! We successfully launched a very meaningful and memorable brand, the Dragonfly™.
With the launch of this brand and a first use case cleared by the FDA, we are excited about entering the next phase of the company growth cycle. In this next phase, we will drive commercial adoption of our first product and make strategic decisions that enable us to bring the Dragonfly technology to additional use cases even faster than planned. What is driving us at our core is that we know with conviction that this technology needs to be used across all of sports medicine, and we owe it to our surgeon customers and the patients they serve to bring this technology to multiple markets as quickly as possible.
As we implement our plan, we will enhance our company's value more rapidly and effectively. I am confident that we will achieve our goals and continue to surpass them.
Tom Gamache | CEO & Co-Founder
Product Development
Validation &
Production:
① Completed validation labs; designs for implants and instruments are now frozen.
② Initiated production builds for meniscal root indications and finalizing procedure pack layouts.
Usability &
Pipeline Expansion:
③ Finished usability labs for ACL repair, proximal biceps, Achilles, syndesmosis, and AC joint.
④ Advancing our implant pipeline with innovative embodiments that open new use cases.
Intellectual Property & Partnerships:
⑤ Strengthening our patent portfolio with 13 issued and 30+ pending patents.
⑥ Completed quality assessments and approved core suppliers; finalizing logistics partnerships for seamless delivery.
This Dragonfly technology is really interesting, because it's a complex technology that makes the system easy to use.
- Kyle Borque, MD
Commercialization
01.
Product
Implants and instruments will arrive in Q2 with first surgeries immediately following.
Made in the USA - our costs and supply chain is not impacted by the recent tariffs in the news.
02.
Sales Channels
We are narrowing down our sales channels based on surgeon profile, distributor fit, and deal size/scalability. Distributor agreements are scheduled to roll out in April.
03.
Customer Segments
Alpha sites are being selected, surgeons have been engaged, and with our recent 510(k) clearance, account activation (VAC) process is underway.
04.
Brand
The Dragonfly has taken flight and the Nativerse is growing. LI campaigns, the reimagined website, targeted customer engagements, and March’s AAOS splash has put Native and Dragonfly on the map. And the market is responding. The result of these efforts is such that we’ve created a pervasive brand and a backlog of surgeon and sales distributor demand.
LOOKING FORWARD
Where the Rock Stars of Sports Medicine Shine
We are preparing for our first surgery, anticipated within the next 8 weeks! AOSSM will be in Nashville in July. This is the largest gathering of Sports Medicine surgeons in the US, and it’s in our backyard. Similar to AAOS in March, we will hit this with force.
1300+ Healthcare Providers
200+ Featured Speakers
200+ Poster Presentations
85+ Exhibitors
60+ Paper Presentations
12 Instructional Courses
Market Insights
We are not alone in the repair movement. Some recent and relevant publications validate and reinforce our commitment to the #savetheknee movement.
Did You Know?
Root Repair Has Superior Radiological and Clinical Outcomes Than Partial Meniscectomy and Nonoperative Treatment in the Management of Meniscus Root Tears
Studies Included: 56 studies with 3,191 patients.
Key Findings:
Repair strategies described in the literature for meniscal root tears (MRT) are highly variable, and newer procedures are being developed to augment traditional approaches to address continued challenges such as meniscal extrusion.
The natural history of unaddressed MRTs is associated with worsening arthritis and a relatively high rate of arthroplasty.
Patient-Reported Outcomes: Root repair showed the greatest improvements in scores like IKDC and Lysholm.