/ 00 Contents

Table of Contents

/ 01 Engagement

Scope & Process

What was reviewed, what was not, and where the evidence came from. The diligence gaps on p.30 and p.31 continue from here.

Limitation of scope

This report is based on documents made available in the data room, public data sources, published literature, and Apollo enrichment as of the dates above. It is not a legal opinion, a financial audit, or a clinical evaluation. Pilot-study raw data were not re-analyzed. The inactive co-founder cap-table disclosure and the university waiver scope should be confirmed in writing by Thornquist Ridge's counsel before close.

Prepared by Matt Kowalczyk · CEO, Amplify&. Distribution limited to Thornquist Ridge Partners and named affiliates.

Company

Tarrowin Medical, Inc. · Mid-Atlantic · incorporated Dec 2023 · full-time June 2024

Sector / Stage

Medical device · connected incentive spirometer · pre-seed, pre-510(k)

Round

$800K · YC post-money SAFE · $5M cap · 20% discount · 1× liquidation · pro rata rights included

Recommendation

$250K, conditional on written disclosure of the inactive co-founders' vesting before wire and a pre-specified multi-site trial protocol. $500K is not supported until the protocol exists.

Calibrated Score

3.24 / 5.0 · threshold 3.50 · April 30 report: 3.63 under the prior method

Weights

Team 0.286 · Technical 0.238 · Market 0.190 · Financial 0.143 · Commercial 0.095 · Deal 0.048 · calibration interview 2026-04-30

Technology precedent

Reminder-equipped spirometers: one independent randomized trial (Eltorai 2019), no hospital adoption. Incentive spirometry itself: no demonstrated effect on complications (Cochrane 2012, 2014).

Investment Thesis

Two bioengineering founders from the Ashbury engineering school propose a connected incentive spirometer that prompts the patient, records volume and use, and reports both to the care team. Their position: adherence rises, stay falls, and hospitals pay about $100 per patient from the margin a shorter stay creates under bundled payment. The return: a respiratory-care consolidator buys a cleared product with evidence and early sales.

The device exists and was used by 30 patients in a company-run, single-arm pilot at one health system. The pilot reports an association between more sessions and shorter stays; it has no control arm and no complication endpoint. The independent evidence is one 160-patient randomized trial that doubled adherence and reduced atelectasis severity, with stay and mortality effects confined to a subgroup, and two Cochrane reviews that find no complication benefit from the therapy. The IP is sound, the regulatory path short, and the incumbent line belongs to a growing, PE-backed consolidator. The clinical claim, and the price it must support, set the score.

/ Memo Company · Market

Company Overview

Tarrowin Medical is a Mid-Atlantic pre-seed company incorporated in Delaware in December 2023. Its founders, Ethan Marlowe (CEO) and Priya Raghavan (CTO), hold bioengineering degrees from the Ashbury engineering school and went full-time in June 2024 after a period of student research and customer discovery. The product is a handheld incentive spirometer with onboard sensing and display that prompts the patient at intervals, records inspiratory volume, flow, and session count, and reports them to a companion application and a clinician view. Apollo lists 5 employees and no institutional funding event. Company age against milestones is typical for the stage: a built device, a 30-patient pilot, a PCT with a favorable opinion, and an SBIR Phase I in about two years of full-time work.

Market

The economic argument depends on bundled payment: a day of stay avoided and a hospital-acquired pneumonia avoided are hospital margin, since neither is separately reimbursed. Nineteen procurement conversations run by the company (three summarized in the data room) say the same thing: value-analysis committees will pay a premium for a device that demonstrably shortens stays. The April report also cited remote-therapeutic-monitoring CPT codes as a reimbursement layer. Those codes apply to outpatient monitoring of a discharged patient; inpatient use of an incentive spirometer is inside the DRG, and no separate payment exists for it. The revision removes that claim.

What the company says distinguishes it

The company's differentiation is that no existing product measures adherence, so no hospital can act on it, and that its device does so in a standalone form factor without a phone. That is true as far as it goes. The question the rest of this report asks is whether adherence, once measured and prompted, changes an outcome a hospital pays for, and the evidence on that is the subject of p.11.

/ Memo Product · Team

Product / Technology

A Class II incentive spirometer (21 CFR 868.5690, product code BWF) with a display, flow and volume sensing, haptic and audible prompts, and a cloud data layer serving patient, user, and provider views. The company's regulatory consultant (company-engaged; letter of February 2025) identified a predicate, judged the 510(k) route sound, and recommended against a pre-submission; the device is eligible for third-party review. No design-history file, risk file, or verification report is in the data room; the company states volume accuracy was checked against an ISO-certified calibration syringe. The PCT (filed September 2024, priority September 2023) received a written opinion from the International Searching Authority finding novelty, inventive step, and industrial applicability on all 20 claims; the company reports national-phase prosecution in seven jurisdictions. The university's waiver of any claim to the IP is in the data room.

Team

/ Memo Financials · Round · Suggested Structure

Financials and company age

Pre-revenue. 2025 total burn was $137K against $130K of grant and competition income (income statement in the data room, Company-reported; the 2023 and 2024 federal returns are Documented). In that period the company built the device, ran the 30-patient pilot, and prosecuted the PCT. The non-dilutive record is one NIH SBIR Phase I award of $300K (award letter, Documented), a $300K state grant pending, and a $2M SBIR Phase II the company planned to submit in April 2026; its status is unknown. Cash buffer on the $800K raise is 17% by the company's own use-of-proceeds, against Thornquist Ridge's 20% reserve threshold.

The five-year model runs $238K (2026) to $10.9M (2030) and contains an apparent error in the 2029 to 2030 expense line. The revenue ramp from $1.6M (2028) to $10.9M (2030) assumes 510(k) clearance on time and adoption faster than the company's own procurement notes describe (two- to three-week trials, multi-month committee review, three-year contracts, 80% GPO compliance). The model is a planning document; a corrected version is a request on p.32.

Round Mechanics

Standard YC post-money SAFE, $800K target, $5M post-money cap, 20% discount, 1× non-participating, pro rata rights included. The no_pro_rata_rights_offered deal-breaker clears. Pre-seed device pricing runs $3M to $10M pre-money; $5M post is at the low end of that band. No lead investor is named in the data room.

Suggested Deal Structure

/ 03 Claims

What you have to believe

The company's value proposition, reduced to the claims an investor has to accept, and how far each has been verified. The company's statement of the product: "a digital incentive spirometer that improves adherence, shortens length of stay, and replaces the $5 plastic standard of care."

Continued on the next page.

/ 03 Claims, continued

What you have to believe

Claims 04 to 06, and the count.

Two of six claims are Verified (the reminder concept, by an independent trial on another device; the IP opinion, pending grants). One is Documented from a company-engaged source. Two rest on company-produced evidence. One is Contradicted in part: the reimbursement layer described in the deck does not apply to inpatient use. Claim 03 gates the thesis and is analyzed on p.11 and p.12.

/ 03b Target product profile

Target Product Profile

The company has not written one. This profile is assembled from the deck, the pilot poster, the consultant letter, and the procurement notes; each line carries the status of its evidence.

Of eleven lines, three are Verified, two Documented, four Company-reported, one Unverified, and one Contradicted for the inpatient use case. The profile of a device company at this stage is normally this shape; the lines that decide the investment are efficacy target and reimbursement, and both need work the current round does not fund.

/ 04 The gating claim

Device-driven adherence shortens stay and reduces pulmonary complications in a controlled, multi-site study

A value-analysis committee will pay a premium for a shorter stay or an avoided pneumonia it can attribute to the device. Without that attribution the product competes on price with a $5 disposable.

Evidence inventory

One company pilot with no control arm, one independent randomized trial of the concept on another device with mixed outcomes, two systematic reviews that find no benefit from the underlying therapy, and a payor-side opinion on what a purchasing committee would need. The critique follows.

/ 04b The gating claim, continued

Critique, literature, and conclusion

Prior attempts and the field

Incentive spirometry has been standard post-operative practice since the 1970s on physiological reasoning; outcome evidence was never produced, and guideline bodies have repeatedly noted the lack of proof. Reminder and tracking devices have been built before, including the use-tracking spirometer in the independent trial, and none has reached routine hospital adoption. Digital respiratory adherence has one commercial precedent, Propeller Health's inhaler sensor, which sold to ResMed in 2019 on the strength of published adherence studies and payer and pharmaceutical contracts, in an outpatient setting with a reimbursement path. The nearest hospital-side analogy, connected hand-hygiene monitoring, sold on compliance data without outcome trials. Tarrowin's route may be the same: prove adherence, sell the data, and let the outcome question be answered over time. That is a smaller product than the deck describes and it is the one the evidence currently supports.

Risks & Mitigants

The five that decide the investment, with their tier. The full register with tiers, severity, and likelihood is on p.29.

First-time founders, a two-person executive team, an 18-month path to revenue, and hospital procurement cycles are real and are stage-normal for a pre-seed device; they appear in the register and are not counted against the deal beyond what the rubric anchors already price. The model's 2029 to 2030 error and the missing use-of-proceeds breakdown are housekeeping and appear as requests on p.32.

Pillar scores are the analyst's composite read and are informed by the six dimension scores without being averages of them. Every pillar sits below the 3.5 threshold in this revision; none is far below it.

Small burn, real grant income, and a built product; a round sized just under the client's reserve rule and a model that cannot yet carry an IC vote.

Two first-time founders who have executed well for two years, with one exit-experienced part-time officer, and an equity question that a buyer will ask before Thornquist Ridge has finished asking it.

The device works as a device and the IP is early and favorable; the clinical claim that gives the device its price is untested, and the manufacturing and software content of the 510(k) is undocumented.

Layer scores · medical device weights

The category is consolidating in the hands of two well-capitalized consumables companies, the digital adjacents are small and shrinking, and the product's opening is a clinical claim nobody has proven.

Field base rate · what happened to prior attempts

Incentive spirometry has been standard of care for fifty years without outcome evidence; two Cochrane reviews and a 2018 clinical review find no demonstrated effect on complications. Devices that track or prompt use have been built and trialed (the use-tracking spirometer in Eltorai 2019) without reaching adoption. The digital-spirometry companies that exist sell diagnostic spirometers to pulmonology clinics, a different product and buyer. The one commercial success in connected respiratory adherence, Propeller Health (sold to ResMed, 2019), was an outpatient product with published adherence data and payer contracts. The company's stated reason to differ is that a standalone device with reminders and clinician reporting can be adopted inside the inpatient workflow; that claim has a 30-patient pilot behind it.

Competitive set · incumbents and adjacents

Headcount change over 24 months per Apollo, shown as the one independently sourced measure of organizational trajectory available for private and public companies alike. Medline's April figure is for the whole company.

/ II.4b Exit path

Who buys this, and what they need to see first

Acquirers are listed by the category they buy in: hospital respiratory-care consumables and devices, and connected respiratory adherence. Category precedent means a named acquisition in that category in the last five years. BD (no respiratory-care business since its 2018 Vyaire divestiture) and Teleflex (a seller: its acute-care, urology, and OEM units were sold for $2.03B in December 2025) appeared in the April table and are removed.

Headcount change per Apollo as above. Six acquirers with means and category precedent, against a reference-class median of two or three for a pre-revenue hospital consumable (our judgment from Appendix A2). Every precedent was a product line with revenue or, in ResMed's case, a company with published studies and payer contracts. None bought a pre-clearance device.

/ II.4c Exit path, continued

Minimum evidence package, and what it costs

Return arithmetic on a $250K SAFE

$250K at a $5M post-money cap is about 5% before dilution. After a seed round and pool top-up, perhaps 3 to 3.5%. A $60M to $150M acquisition of a cleared device with a published outcome study and early revenue returns roughly 7 to 20× on the SAFE; a $20M to $40M sale of a cleared adherence device without an outcome study returns 2 to 5×. Thornquist Ridge's stated target for pre-seed is 10×; the upper outcome reaches it and the fallback does not.

Where this feeds the score

D6 (p.28) takes the terms and this path; the package can be estimated, so the cap for an unestablished exit path does not apply, and the score reflects a real but conditional path with a modest fallback. D2 takes the field base rate and the competitive set (p.18).

Investment Thesis Alignment

Every criterion in Thornquist Ridge's calibrated profile, mapped to the evidence. The hard-pass rows decide whether the deal can be considered; the rows above them describe fit.

Thornquist Ridge Rubric · Weighted Overall

Six dimensions scored 0 to 5, weighted by the client's calibrated profile (Team and Technical carry 52% of the weight), summed against the 3.50 pre-seed threshold.

Threshold 3.50 · Result Below threshold · margin −0.26 · three-lens range Bear 2.64 / Base 3.24 / Bull 3.82. The bull case clears the threshold; the base and bear cases do not.

Dashed ring = 3.50 threshold. Only D6 reaches the ring. The April report's polygon cleared the ring on D3 and D6; the changes are explained in Appendix B.

Efficient use of very little capital, one grant in hand, a buffer just under the client's rule, and the decisive study unfunded.

Three-lens spread · Bear 2.8 (Phase II declined; bridge before any study) · Base 3.4 · Bull 3.9 (Phase II awarded; model corrected). The April report scored 3.5; the revision counts the unfunded study.

A large installed base, a bottom-up unit count, an unpaid price, an adverse evidence base for the underlying therapy, and two consolidators who own the category.

Three-lens spread · Bear 2.4 (incumbent adds sensing; price falls to the disposable) · Base 3.0 · Bull 3.6 (readout positive; committee adoption at the company's price). The April report scored 3.6 on the incumbent's collapse, which did not happen to the product line.

Thornquist Ridge's second-highest weight. The composite of four layers scored on p.17: evidence 3.0, IP 4.0, regulatory 3.8, manufacturability 2.8.

Three-lens spread · Bear 2.8 (readout negative; 510(k) delayed on software content) · Base 3.4 · Bull 4.0 (readout positive; grants issue). The April report scored 4.0 by treating the pilot and the opinion as a completed evidence package; the revision scores the layers separately.

Thornquist Ridge's heaviest dimension. Two-year execution by first-time founders, one part-time exit-experienced officer, and an 18.3% question.

Three-lens spread · Bear 2.6 (an inactive co-founder disputes the shares; the CEO's bandwidth breaks) · Base 3.2 · Bull 3.8 (disclosure complete; a device operator joins). The April report scored 3.4; the revision scores category and technology history explicitly.

Unusual depth of clinician interest for the stage, no money changing hands, and a reimbursement story that has to be rewritten.

Three-lens spread · Bear 2.4 (committees decline without an RCT) · Base 3.0 · Bull 3.6 (two paid pilots in the trial-requesting sites). The April report scored 3.5 partly on the reimbursement layer; the revision removes it.

Standard YC terms at a low cap, six category acquirers with precedent, and a package that is estimable, fundable, and two to three years away.

Three-lens spread · Bear 3.0 (fallback sale only) · Base 3.6 · Bull 4.2 (readout positive; two consolidators compete). The April report scored 4.0 with BD and Teleflex as buyers; the revision removes both and prices the distance to the package.

/ 06 Risk & Process

Risk Register

Nine active risks: one Existential, five Structural, three Stage-normal. Six independent existential or structural risks against a norm of two or three for a pre-seed device. Housekeeping items are on p.32.

Existential and Structural items only.

/ 07a What was not done, before IC

Diligence Gaps · Pre-IC

Analyst-time items Thornquist Ridge should weigh before an IC vote. The "what would settle it" column on p.08 feeds this list.

Reference calls, not completed

• Independent clinicians. No respiratory therapist, thoracic or cardiac surgeon, or nursing director without a tie to the company has been asked whether they would change practice for adherence data, or what evidence their committee would require. Independent means no letter of support, no advisory role, no co-authorship. Three calls; one week.
• Value-analysis committee members. The company's 19 conversations are its own notes. Two independent calls with committee chairs at non-Ashbury systems would test the "would adopt on single-site evidence" statement.
• Thomas Beckett. The Tessamere sale and his current time allocation are unverified.
• Founders' prior employers at the venture fund and the growth fund.

Evidence verification, not completed

• Pilot data. We read two posters. Patient-level data, the June poster's adherence baseline, and any pneumonia or complication counts were not obtained.
• Independent regulatory review. The predicate, the software documentation level, and the cybersecurity content have been assessed only by the company's consultant. $10K to $20K.
• Freedom to operate. Not obtained; the ISA search cited four documents and found the claims novel over them, which is not the same question.
• Bill of materials. No cost data reviewed; the $100 price and the model's margin are unsupported until it exists.
• SBIR Phase II status. Planned for April 2026 submission; unknown at revision.

/ 07b What was not done, before wire

Diligence Gaps · Pre-Wire

Counsel and operational items to resolve in writing before any funds move, whatever the IC decides on size.

Corporate and legal, not completed

• Inactive co-founders. Vesting status, repurchase rights, separation terms, and any disputes for Halloran, Petrakis, and Nair. The condition precedent.
• Cap table verification. The March 2026 table is company-prepared; a counsel- or platform-verified table with founder vesting and the pool.
• University waiver scope. The letter is in the data room; counsel should confirm it covers the PCT claims and any improvements made with university resources.
• Contractor IP assignment for any firmware or design work done outside the founders, including interns (the intern offer letter template is in the data room; signed assignments are not).
• Background checks on both founders, standard for any check above $250K.
• Tax and insurance. 2023 and 2024 returns reviewed; state compliance not verified; insurance certificates current.

Deal documents, flagged

• Executed SAFE. Only a blank template is in the data room; confirm pro rata and the cap in the executed instrument.
• Use of proceeds. A written breakdown of the $800K with a 20% reserve before signing.
• Tranche mechanics. If Thornquist Ridge invests $250K with a second $250K contingent on the trial protocol, paper the second as a separate SAFE at the same cap.
• Conflict check. Confirm no overlap between Amplify& personnel and the company's advisors or officers.

Sequencing

Pre-IC items are analyst time and can be completed inside two weeks. Pre-wire items are counsel time and follow the IC decision. Amplify& can scope a follow-up engagement covering the pre-IC items on request.

/ 08 Detailed recommendation

Recommendation ·
Detailed

Relative to the alternatives

Thornquist Ridge's typical pre-seed position is $250K to $1M in a Mid-Atlantic health-technology company with a strategic exit in four to seven years. Within that mandate, a cleared 510(k) device with a published outcome study would carry two or three independent risks; Tarrowin carries six, of which one is existential. The $5M cap and standard terms compensate for the stage; they do not compensate for a 30 to 45% probability on the claim that sets the price. The fallback product keeps the downside bounded, which justifies a small position. This is our judgment; the client's calibration sets no check-size ceiling.

Requests to the company

• Corrected five-year model with the 2029 to 2030 expense line repaired and a margin built from a bill of materials.
• Removal of the RTM CPT-code slide from investor materials.
• The June 2025 adherence poster's baseline definition.
• A national-phase status report on the PCT from counsel.
• Signed intern and contractor IP assignments.
• The written protocol synopsis for the planned multi-site study.

/ A Data Sources

Appendix A · Data Sources

Materials reviewed. Each is labeled with its source class where that is not obvious from the item.

1. Pitch deck (32 slides) and a five-minute pitch video. Company-reported.
2. Financial model (7 sheets) and a milestone timeline. Company-reported.
3. Clinical: ClinicalTrials.gov NCT07481236 listing; adherence poster (June 2025) and length-of-stay poster (September 2025). Company-reported.
4. Regulatory: consultant letter, February 2025. Documented; company-engaged source.
5. Payor feedback: written response from ECRI's clinical evidence assessment group (January 2025) and meeting summaries with ECRI and a pediatric Medicaid plan. The written response is Verified; the summaries are Company-reported.
6. Letters of support (21) from named clinicians and institutional leaders at seven health systems, a device design firm, and a regional science center. Company-solicited.
7. IP: PCT/US2024/046166 as filed; ISA search report and written opinion (December 2024); provisional as filed; university waiver letter; trademark registration. Verified and Documented; read in full.
8. Customer discovery: procurement notes from three of 19 hospital systems; customer discovery workbook. Company-reported.
9. Team: bios, resumes, NIH biosketches; cap table dated March 2026. Company-reported.
10. Tax and insurance: 2023 and 2024 federal returns; business owner's policy; workers' compensation; insurance application. Documented.
11. Corporate: articles of incorporation (Delaware, December 2023); clinical trial research agreement with the university health system; intern offer letter template. Documented.
12. Round: blank YC post-money SAFE. Template only.
13. Literature located independently: Eltorai et al., JAMA Surgery 2019 (reminder spirometer RCT); Cochrane reviews of incentive spirometry after CABG (2012) and upper abdominal surgery (2014); Eltorai et al., Respiratory Care 2018 (clinical effectiveness review); AHA and CMS utilization statistics for the inpatient unit count. Verified.
14. Apollo enrichment, 2026-04-30: Tarrowin, Vyaire, Medline, ICU Medical, MIR, ndd, patientMpower (7 credits). Apollo enrichment, 2026-09-21: AirLife, Baxter, Zoll, ResMed (4 credits). Apollo figures trail real time by 30 to 60 days.
15. Public disclosures: SunMed/AirLife, Vyaire, Zoll, Medline, Teleflex, ICU Medical, ResMed, and Baxter transaction releases and trade press.
16. Thornquist Ridge Partners calibrated client profile, from the interview of 2026-04-30.
17. Amplify& report of 2026-04-30 on the same data room, superseded by this document.

/ A2 Precedent status

Appendix A2 · Precedent Status

Every transaction, company, and study cited in this report, with its status as of the check date. Companies cited in the April report that do not belong in the acquirer set are listed with the reason.

1. SunMed acquisition of Vyaire Medical's respiratory and anesthesia consumables (completed June 2023): the incentive spirometer line moved with it; SunMed rebranded as AirLife in 2024. Status checked 2026-09-21.
2. AirLife acquisition of Avanos Medical's respiratory business (October 2023): completed. Checked 2026-09-21.
3. Vyaire Medical: filed Chapter 11 in June 2024; ventilator business sold to Zoll (August 2024, $37M). The April report's "−87% headcount" described this remainder, not the product line the company competes with. Checked 2026-09-21.
4. Medline acquisition of Teleflex's Hudson RCI respiratory consumables (completed June 2021): included incentive spirometers; line active. Checked 2026-09-21.
5. ICU Medical acquisition of Smiths Medical (January 2022, $2.35B): completed; integration ongoing. Checked 2026-09-21.
6. ResMed acquisition of Propeller Health (announced December 2018, about $225M): completed 2019; product line active. Connected-adherence precedent, outpatient. Checked 2026-09-21.
7. Baxter acquisition of Hillrom (December 2021, $12.5B): completed; Baxter has since divested other units and its market capitalization is about $12B. Checked 2026-09-21.
8. Teleflex: agreed in December 2025 to sell its acute-care, interventional urology, and OEM businesses for $2.03B. A seller in this category; removed from the acquirer set. Checked 2026-09-21.
9. BD: no respiratory-care business since the 2018 Vyaire divestiture; the April report named it "most likely strategic." Removed. Checked 2026-09-21.
10. Danaher acquisition of Masimo (February 2026, $9.9B): patient monitoring; not a respiratory consumables buyer; noted for completeness. Checked 2026-09-21.
11. Eltorai et al. 2019, JAMA Surgery: published; no correction found; no multi-site replication found. Checked 2026-09-21.
12. Cochrane reviews, 2012 and 2014: current versions unchanged in conclusion at check. Checked 2026-09-21.
13. NCT07481236: listed; single-arm; results unpublished beyond posters. Checked 2026-09-21.
14. MIR, ndd, patientMpower: active; no transactions found since April. Checked 2026-09-21.

/ B Methodology

Appendix B · Methodology

The Four Pillars are the prose read of the evidence; the six dimensions are the scored read of the same evidence, weighted to the client's priorities; the score comes from the six dimensions only. Weights are from the Thornquist Ridge calibration interview of 2026-04-30: Team 0.286, Technical 0.238, Market 0.190, Financial 0.143, Commercial 0.095, Deal Terms 0.048. Pre-seed proceed threshold 3.50. Weighted score 3.24.

Every material fact carries a source class. Verified: confirmed by an independent source (registry, regulator, peer-reviewed publication, our own interview). Documented: a third-party document in the data room. Company-reported: a document the company produced or solicited. Unverified: an assertion without a document. Company-reported and Unverified facts are attributed in the sentence wherever they appear; advisors, consultants, and endorsers engaged by the company are described as company-engaged.

The value proposition was reduced to six claims and each was verified separately. The gating claim was analyzed on its merits and its conclusion governs where it and the weighted score diverge. Risks carry a tier; housekeeping is excluded from the register. Acquirers are organized by the category they buy in, with a named precedent. Every precedent was status-checked on 2026-09-21. Technical merit was scored as four layers with medical-device weights (evidence 0.35, IP 0.20, regulatory 0.25, manufacturability 0.20).

Three-lens scoring

Each dimension was scored three times: skeptic (the flagged risks materialize), optimistic (the company's plan executes), and pragmatic (the base rate for a pre-seed 510(k) device from a university spinout). The pragmatic case is reported; the other two bound the range. Scenario weights from the client profile are 0.30 / 0.50 / 0.20.

Probability-weighted value (0.30 / 0.50 / 0.20) 3.18; PERT 3.24. The bull case clears the threshold and depends on one event, the multi-site readout.

Why the score changed from April

The data room is the same. D3 fell from 4.0 to 3.4 because the single-arm pilot and the search-authority opinion had been treated as a completed evidence package; the layers are now scored separately and manufacturing is counted. D2 fell from 3.6 to 3.0 because the incumbent product line was found to be owned by a growing consolidator (the April report described a collapsed company), the underlying therapy's evidence base is counted, and the inpatient reimbursement claim was removed. D5 fell from 3.5 to 3.0 on the same reimbursement correction. D6 fell from 4.0 to 3.6 because BD and Teleflex were removed from the acquirer set and the distance to the evidence package is priced. D4 fell from 3.4 to 3.2 on explicit scoring of category history. D1 fell from 3.5 to 3.4 because the decisive study is unfunded by the round. The April recommendation of $250K to $500K stands at its lower bound.