Hims & Hers CEO Andrew Dudum in support of the company’s expansion into cardiovascular care.

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Digital Health

Hims’ Dual-Action Cardiovascular Health Expansion

Massive direct-to-consumer health and wellness company, Hims & Hers, announced an unexpected expansion into cardiovascular care last week with the launch of Heart Health by Hims.

Noting that erectile dysfunction is an early sign of cardiovascular disease, Heart Health by Hims will leverage the company’s position as a leading ED treatment provider as it tries to become a next-gen CVD detection and preventative care company.

• And they plan to do this by prescribing a single daily “2-in-1” pill that combines the ED medication tadalafil (Cialis) with the CVD medication rosuvastatin. 

Through its “dual-action approach” to CVD care, Hims will… 

• Identify platform users who present signs of CVD risks during the ED treatment intake process
• Educate these patients about their CVD risks, while also informing their Hims care platform provider to explore cardiovascular treatments 
• Have its providers consult with the patients, and potentially prescribe the 2-in-1 combo pill (at customized dosage) if deemed appropriate

To support key processes and likely to build cardiology trust, Hims & Hers simultaneously launched alliances with the ACC (focused on CVD risk assessments and patient education tools) and Labcorp (focused on lab-based heart health testing to support diagnoses).

Hims & Hers has major goals for cardiovascular care. Noting its huge client base of ~1.2M monthly users, and it’s estimate that 30% of Hims ED customers have at least one CVD risk factor, the company vowed to continue to “heavily invest in and expand” in cardiovascular care and eventually “bend the curve” on CVD deaths. 

• The company wasn’t clear about where that future CVD expansion might bring it, but Hims & Hers is reportedly eyeing an expansion into GLP-1 weight loss meds, and it has a wide range of other platform users who might have higher CVD risks but don’t require ED treatments (including women).

The Takeaway
Hims & Hers’ new Heart Health service is vastly different from what many Cardiac Wire readers are accustomed to (or even comfortable with). However, this DTC approach could prove to be an effective way to increase CVD diagnosis and treatment, especially given Hims’ massive pipeline of male clients and considering that ED meds have far greater adherence rates than statins.

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The Wire

• Cleerly’s 10-Year Predictions: A new JACC study found that Cleerly’s coronary CTA AI solution can effectively gauge long-term CV event risks. Researchers used Cleerly AI to classify plaque burdens among 536 patients with suspected CAD (burdens stages: 0-3), and then analyzed their 10-year outcomes. Patients with stage-3 plaque burdens had over 3-fold higher risk of MACE than stage 0 or 1 patients (adjusted HR: 3.57), while Cleerly AI improved 10-year MACE prediction accuracy compared to a model using clinical risk factors and CAC scores (AUC: 0.82 vs. 0.73).

• Misdiagnoses Linked to 370k Deaths Annually: A new BMJ study attracted a lot of attention last week after finding that the full impact of misdiagnoses in the U.S. is likely being seriously underestimated. The researchers estimate that 371k people die every year following a misdiagnosis, and 424k are permanently disabled – meaning nearly 800k people suffer “serious harm” annually. Interestingly for Cardiac Wire readers, the authors highlighted the recent improvements in heart attack diagnosis as an example to follow for other areas of medicine.

• Abbott’s Trifecta Withdrawal: Abbott announced plans to withdraw its Trifecta family of SAVR valves from the US market due to their “potential for early Structural Valve Deterioration.” Abbott will remove remaining Trifecta valve inventories, and is working with the FDA on post-market surveillance of patients with prior Trifecta implants. The Trifecta withdrawal comes amid Abbott’s increased focus on tissue heart valve solutions, while eliminating a SAVR competitor for Medtronic and Edwards.

• CMS Finalizes 3.1% Hospital Bump: CMS finalized a 3.1% payment increase for hospitals for 2024, a slight increase from the 2.8% bump proposed earlier this year. Despite the upwards revision, hospital groups have been outspoken against the final rule. Hospital purchasing group Premier pleaded that “CMS can and must do better to adopt new or supplemental data sources to calculate the real costs hospitals incur moving forward,” while Federation of American Hospitals CEO Chip Kahn said the increase “falls far short.” 

• Behavioral Support Cuts Cardiovascular Readmissions: A recent study in The Journal of Healthcare Management found that post-acute behavioral support can have a major impact on cardiovascular patient readmissions. The intervention group of 193 CVD patients received post-discharge support via the Laguna Health app (emotional coaching, personalized recovery plans, mindfulness training), resulting in significantly lower total readmission costs ($1.1M vs. $2M for the usual care group) and lower average costs per readmitted patient ($44k vs. $91k).

• Ultromics’ HFpEF Performance: A new Mayo Clinic-led study highlighted Ultromics’ ability to improve HFpEF detection using a single echo view. The researchers applied the Ultromics EchoGo Heart Failure solution to 1,284 patients’ echo exams, achieving 87.8% sensitivity and 81.9% specificity (above typical clinical performance without AI). They then applied the solution to 701 and 776 patients who had non-diagnostic HFA-PEFF and H2FPEF scores, finding that the AI model correctly reclassified 73.5% and 73.6% of these indeterminate cases.

• Ultromics Earns NTAP Reimbursement: Ultromics’ hot streak continued after CMS added its EchoGo Heart Failure software to the New Technology Add-on Payment (NTAP) program, with Medicare reimbursing the HFpEF detection solution at a rate of $1,023 per acute hospital inpatient stay. Ultromics’ new (but temporary) inpatient reimbursement comes shortly after a new HCPCS code that will cover EchoGo use in outpatient settings.

• Good News for SubQ ICD: A long-term post-approval study published in JACC revealed that Boston Scientific’s subcutaneous implantable cardioverter defibrillator (S-ICD) system achieved robust effectiveness and safety for up to five years. The BSCI-sponsored prospective study enrolled 1,643 S-ICD patients, including 665 who completed final follow up. The device’s overall effectiveness treating spontaneous discrete ventricular arrhythmia was 98.4%, with lasting results, while 93.4% of patients were complication-free.

• Google Unveils MedPaLM M: Google took the lid off its latest Med-PaLM M multimodal generative model, representing what could be a major milestone in the development of generalist biomedical AI systems. Unlike its large language model predecessors, Med-PaLM M can interpret biomedical data across text, imaging, and genomics, allowing it to perform a wide range of tasks across multiple modalities (e.g. generate diagnostic imaging reports). Exciting preliminary evidence also suggests that Med-PaLM M can generalize to novel use cases, despite having never encountered the disease.

• Physicians Lack Trust in Leadership: A physician survey from strategic communications firm Jarrard found that only 36% of physicians at not-for-profit health systems agree that their leaders are honest and transparent (vs. half of physicians at investor-owned systems). Only half of physicians trust leadership decision-making when it comes to operations and patient care, and instead place the highest levels of trust in their peer physicians. When asked what would improve trust, “transparency” was unsurprisingly the most common response.

• HF AFib Risks: New analysis in JACC highlighted HFpEF and HRmrEF patients’ high risk of AFib, while finding that atrial shunt therapy for HF didn’t affect AF incidence or burden. The researchers analyzed one year of data from 367 patients who participated in an atrial shunt study, finding that subclinical AFib was extremely common in this group (38% identified with subclinical AF by 1yr) and participants with a median baseline AFib burden of ≥ .012% had twice the risk of heart failure events during the study period (HR: 2.00).

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The Resource Wire

• Monebo’s Kinitec Rhythms ECG Algorithm separates true ECG signals from background noise, leading to more accurate diagnoses and improved operator efficiency. See for yourself how the algorithm measured up to a gold standard.

• Us2.ai published what might be the most comprehensive paper we’ve seen on AI echo, detailing the benefits of AI-automated echocardiography, the global need for more scalable and flexible CVD assessments, and how its technology is fit for the future. If you’re focused on the echo, echo AI, or echo accessibility and efficiency, this paper is worth checking out.

• For years, world-renowned prevention expert Dr. Arthur Agatston, author of The South Beach Diet and developer of the “Agatston Score,” had been looking for technology that could accurately identify all types of plaque in the heart. Then, he was introduced to Cleerly. Hear from Dr. Agatston on why he believes “Cleerly really is the holy grail of prevention.”