Industry Partnership

RESTORA · 复元 Strategic Partnership Invitation · 战略合作意向书

智能康复伴侣 · Smart Recovery Companion

Aika Lab
·
Restora · 复元 Restora · Restore
AIKA LAB · AI PLAYER IN GOTHENBURG

RESTORA · 复元

智能康复伴侣 · Smart Recovery Companion
战略合作意向书
Strategic Partnership Invitation
致 各潜在合作伙伴
项目方:Aika Lab · AI Player in Gothenburg, Sweden
文档版本:v0.1 · 发布日期:2026 年 5 月
保 密 文 件
本文件仅供受邀对话伙伴查阅,未经书面许可不得向第三方披露或转发
AIKA LAB · AI PLAYER IN GOTHENBURG

RESTORA

Smart Recovery Companion · 智能康复伴侣
Strategic Partnership Invitation
A Letter to Future Industrial Partners
To: All prospective partners
From: Aika Lab · AI Player in Gothenburg, Sweden
Version v0.1 · Released: May 2026
CONFIDENTIAL
For invited dialogue partners only. No third-party disclosure or forwarding without written permission.

致 函 A Letter to You

尊敬的合作伙伴:

感谢您愿意花时间阅读本文件。

Restora · 复元 是 Aika Lab 团队历经数月研究后启动的旗舰项目,旨在为全球数亿骨科术后患者打造一款真正能在家完成临床级康复的智能可穿戴产品。我们已经完成了完整的立项研究:包括国际竞争分析、文献综述、产品 PRD、初步设计方案、采购指南、视觉系统 brief、两阶段商业化策略与投资人材料,共计八份核心文档。

我们清楚地认识到:从一份周到的研究、扎实的算法和系统设计,到一台真正进入家庭、走进医院、获得监管许可的医疗级产品,中间还有「产业落地、规模化生产、临床取证、市场销售」四道关键的桥。这恰好是我们想邀请您一起搭建的部分。

本意向书将向您完整呈现:项目背景与全球现状、技术与产品方案、商业愿景、可行性论证,以及我们希望共同探索的合作模式。如果您是有实力推进此类创新医疗 / 大健康产品落地的企业或创业者,我们非常期待与您建立深度对话。

—— Aika Lab 项目团队
2026 年 5 月 · 瑞典哥德堡

Dear prospective partner,

Thank you for taking the time to read this document.

Restora is the flagship project of Aika Lab, a Gothenburg-based AI player. After months of research, we are launching this initiative to build a smart wearable device that finally enables hundreds of millions of orthopedic post-surgery patients worldwide to undergo clinical-grade recovery at home. We have already completed a comprehensive project foundation: eight core documents covering international competitive analysis, literature review, product PRD, preliminary design, procurement guide, visual system brief, two-phase commercialization strategy, and investor materials.

We recognize clearly: between a thoughtful research package and a real, medical-grade product reaching homes, hospitals, and regulatory approvals, there are four critical bridges — industrialization, scaled manufacturing, clinical certification, and market distribution. These are precisely the parts we hope to build together with you.

This document presents in full: the project background and global landscape, technical and product solution, business vision, feasibility analysis, and the partnership models we wish to explore together. If you are an enterprise or entrepreneur capable of advancing innovative medical / digital health products to market, we very much look forward to opening a deep dialogue with you.

—— The Aika Lab Project Team
May 2026 · Gothenburg, Sweden

一、项目概述 1. Project Overview

1.1 项目身份卡 1.1 Project Identity Card

项目代号
Restora · 复元(英文主名 / 中文主名)
项目方
Aika Lab · AI Player in Gothenburg, Sweden
产品定位
面向骨科术后康复的无创可穿戴神经干预设备
核心承诺
让身体重回完整 —— 在家完成临床级康复
适应症范围
骨折、关节置换、ACL 重建、脊柱手术等术后康复(0–12 周窗口期)
目标市场
中国 NMPA / 美国 FDA / 欧盟 CE-MDR 三地同步
技术形态
手机端算法驱动 + Type-C 输出 + 模块化外设(耳夹 + 肌贴 + 线圈 + 超声探头 + 传感)
立项阶段
已完成完整立项研究包(8 份核心文档)
Project Name
Restora · 复元 (English / Chinese primary names)
Project Sponsor
Aika Lab · AI Player in Gothenburg, Sweden
Product Positioning
Non-invasive wearable neuromodulation device for orthopedic post-surgery rehabilitation
Core Promise
Let the body return to whole — clinical-grade recovery at home
Indications
Fracture, joint replacement, ACL reconstruction, spinal surgery rehabilitation (0–12 week window)
Target Markets
China NMPA / USA FDA / EU CE-MDR — synchronized three-region launch
Technical Form
Phone-driven algorithms + Type-C output + modular peripherals (ear clip + muscle patches + coil + ultrasound probe + sensors)
Stage
Complete project foundation package finalized (8 core documents)

1.2 项目一句话描述 1.2 One-Sentence Description

Restora 是全球首款将四种主流神经调控模态(taVNS 经皮迷走神经刺激、NMES 神经肌肉电刺激、PEMF 脉冲电磁场、LIPUS 低强度脉冲超声)融合到同一无创可穿戴产品中的智能康复设备,借助手机端算法 + 闭环传感实现个性化、临床级的居家康复,覆盖骨折与骨科术后患者在恢复窗口期内的全部核心需求 —— 促进血液循环、消炎、消肿、加速骨愈合

Restora is the world's first wearable device that integrates four mainstream neuromodulation modalities — taVNS (transcutaneous auricular vagus nerve stimulation), NMES (neuromuscular electrical stimulation), PEMF (pulsed electromagnetic field), and LIPUS (low-intensity pulsed ultrasound) — into a single non-invasive product. Leveraging phone-driven algorithms with closed-loop sensing, it enables personalized, clinical-grade at-home recovery covering all core needs during the orthopedic recovery window: improved blood circulation, anti-inflammation, edema reduction, and accelerated bone healing.

1.3 项目品牌结构 1.3 Brand Architecture

  • 公司主体:Aika Lab(瑞典哥德堡,AI Player in Gothenburg)—— 项目方,承载技术与平台资产
  • 产品 / APP 主品牌:Restora · 复元 —— 面向 C 端患者与医生,承载产品识别
  • 产品线子品牌:Restora Recovery(消费级辅助疗愈)+ Restora Medical(医疗器械级)
  • 品牌护城河:商标 FTO 检索进行中,覆盖中美欧三地主要类目
  • Company entity: Aika Lab (Gothenburg, Sweden) — project sponsor, carrying technology and platform assets
  • Product / APP brand: Restora — patient and physician-facing product identity
  • Sub-brands: Restora Recovery (consumer wellness) + Restora Medical (regulated medical device)
  • Brand moat: trademark FTO clearance in progress, covering primary categories in CN / US / EU

二、项目背景与全球现状 2. Background & Global Landscape

2.1 临床痛点:一个被低估的医疗黑洞 2.1 Clinical Pain Point: An Underestimated Medical Blackhole

全球每年发生约 4 亿次骨折与骨科手术,包括四肢骨折、髋膝关节置换、脊柱融合、运动损伤重建等。在术后 0–12 周这一关键康复窗口期内,患者普遍面临三重压力:

  • 炎症失控:骨折与手术创伤触发 IL-6、TNF-α 等促炎因子大幅升高,过度炎症抑制成骨细胞活性,是延迟愈合的主因之一
  • 微循环受损:石膏 / 支具固定与卧床制动导致静脉淤滞、淋巴回流受阻,引发局部水肿、缺氧与组织修复延迟
  • 肌肉萎缩与神经异常激活:4–6 周制动可使肌横截面积下降 20–40%,并触发交感神经异常激活 —— 这是慢性疼痛综合征(CRPS)的关键风险因子

以腕骨折为例,术后 CRPS 发病率高达 4–37%(依诊断标准而定)。一旦发生,治疗成本相比常规康复上升数十倍,并对功能恢复与重返工作造成长期影响。

然而,这一长达 12 周的康复窗口期目前几乎完全暴露在医疗系统的服务盲区中:三甲医院骨科 / 康复科资源高度紧张、基层医疗无能力承接、居家康复缺乏监测与个性化干预手段、患者与医生在出院后基本失联。

Approximately 400 million fractures and orthopedic surgeries occur globally each year — including limb fractures, hip / knee replacements, spinal fusion, and sports injury reconstructions. During the critical 0–12 week post-op recovery window, patients commonly face a triple challenge:

  • Uncontrolled inflammation: Fracture and surgical trauma trigger large surges in IL-6, TNF-α and other pro-inflammatory cytokines. Excessive inflammation suppresses osteoblast activity and is a leading cause of delayed healing.
  • Microcirculation impairment: Cast / brace fixation and bed rest cause venous stasis and lymphatic drainage disruption, leading to local edema, hypoxia, and delayed tissue repair.
  • Muscle atrophy and sympathetic dysregulation: 4–6 weeks of immobilization can reduce muscle cross-sectional area by 20–40% and trigger abnormal sympathetic activation — a key risk factor for Complex Regional Pain Syndrome (CRPS).

Take wrist fractures as an example: post-op CRPS incidence runs as high as 4–37% (depending on diagnostic criteria). Once it occurs, treatment costs rise by orders of magnitude over standard rehabilitation, with long-term impact on functional recovery and return to work.

Yet this 12-week recovery window is almost completely a service blind spot in today's healthcare systems: tertiary hospital orthopedic / rehabilitation departments are stretched thin, primary care cannot absorb the demand, home-based recovery lacks monitoring and personalized intervention, and patients are essentially disconnected from their physicians after discharge.

2.2 全球神经调控市场进入主流 2.2 Global Neuromodulation Market Entering the Mainstream

神经调控(Neuromodulation)作为一种全新的「非药物」干预手段,正在快速进入医疗主流。根据 Precedence Research 等权威研究机构数据:

$9.07B
2025 全球神经调控市场规模
$28.07B
2035 预测规模
11.96%
CAGR · 2025–2035

骨科 + 康复细分市场目前尚未被独立统计,预示巨大蓝海。

Neuromodulation, as a new "non-pharmacological" intervention category, is entering the medical mainstream at unprecedented speed. According to Precedence Research and other leading market research firms:

$9.07B
2025 Global Neuromodulation Market
$28.07B
2035 Projected Market
11.96%
CAGR · 2025–2035

The orthopedic + rehabilitation sub-segment has not yet been independently quantified — signaling a major untapped market opportunity.

2.3 国际竞争格局 —— 五条技术路线、零产品全覆盖 2.3 International Competition — 5 Technology Tracks, Zero Full Coverage

我们对全球 12 家主要玩家与 5 大技术路线进行了系统分析,得出明确结论:现有产品各自仅解决「康复全景」中的一件事,全球没有任何产品同时覆盖「血流 + 消炎 + 消肿 + 骨愈合」四象限。

技术路线代表玩家局限性
VNS / taVNSSetPoint Medical(FDA 2025-07 批准)、Parasym、Nurosym强在系统性消炎,但骨科适应症的 RCT 接近空白
PEMFOrthofix Physio-StimFDA 1980 年代即批准用于骨不连,但靶点单一,不解决炎症与肌肉问题
LIPUSBioventus EXOGEN、Orthofix AccelStim16 项 Level 1 研究支撑骨愈合,但完全不涉及循环与消肿
NMES / FESCompex、Bioness、PowerDot血流与消肿证据最强,但不消炎、不促骨愈合
SCS / PNSMedtronic、Abbott、Nalu Medical止痛与 CRPS 证据扎实,但属植入式,门槛与成本极高
关键洞察:在国际神经调控产业地图上,「无创 × 多模态融合 × 骨科康复」这一象限 —— 目前是空的。这正是 Restora 锁定的差异化窗口。

We systematically analyzed 12 major international players across 5 technology tracks and reached a clear conclusion: each existing product solves only one piece of the "recovery full picture," and no product worldwide simultaneously covers all four quadrants — blood flow + inflammation + edema + bone healing.

Technology TrackRepresentative PlayersLimitation
VNS / taVNSSetPoint Medical (FDA-approved 2025-07), Parasym, NurosymStrong on systemic inflammation, but RCTs for orthopedic indications are near zero
PEMFOrthofix Physio-StimFDA-approved for non-union since 1980s, but single-target, no inflammation or muscle effect
LIPUSBioventus EXOGEN, Orthofix AccelStim16 Level 1 studies supporting bone healing, but does not address circulation or edema
NMES / FESCompex, Bioness, PowerDotStrongest evidence on blood flow and edema, but no anti-inflammatory or bone-healing effect
SCS / PNSMedtronic, Abbott, Nalu MedicalSolid evidence on pain and CRPS, but invasive (implanted) with very high cost and barriers
Key insight: On the global neuromodulation industry map, the quadrant of "non-invasive × multi-modal fusion × orthopedic recovery" is currently empty. This is exactly the differentiation window Restora targets.

2.4 监管利好与时代窗口同时打开 2.4 Regulatory Tailwinds and Timing Window Both Open Now

  • SetPoint VNS 2025 年 7 月获 FDA 批准,成为首个神经免疫调节疗法
  • Theranica Nerivio 2025 年 8 月获中国 NMPA 批准,是首个进入中国市场的可穿戴神经调控产品
  • PEMF、LIPUS、NMES 各自均有 Level 1 meta-analysis 证据支撑,机制学被 2024 年 Curr Osteoporos Rep 综述系统阐述
  • taVNS、微传感、边缘 AI、PZT 压电换能器小型化等底层技术在 2024 年后均消费级可用
Why Now:技术成熟、监管打开、证据扎实 —— 三个时间窗口在 2026 年同时打开。错过这一时间窗口,可能要再等 5–8 年才有同样的产业机会。
  • SetPoint VNS received FDA approval in July 2025 as the first neuro-immune modulation therapy
  • Theranica Nerivio received China NMPA approval in August 2025 — the first wearable neuromodulation product to enter the Chinese market
  • PEMF, LIPUS, and NMES each have Level 1 meta-analysis support; the underlying mechanisms are systematically reviewed in Curr Osteoporos Rep 2024
  • taVNS, micro-sensors, edge AI, and miniaturized PZT piezoelectric transducers all became consumer-grade accessible after 2024
Why Now: Mature technology, opened regulation, solid evidence — three timing windows aligned simultaneously in 2026. Missing this window may mean waiting another 5–8 years for the same kind of industry opportunity.

三、技术方案与产品定位 3. Technical Solution & Product Positioning

3.1 核心产品架构:手机即算法平台,外设即执行单元 3.1 Core Architecture: Phone-as-Algorithm-Platform, Peripherals-as-Transducers

Restora 在系统架构上做了一个关键判断:把信号生成、调度、个性化算法全部交给手机端完成(基于 Aika Lab 团队多年积累的核心算法能力),外设只承担「转换 + 执行 + 安全保护」的功能。这样做的好处是:硬件门槛大幅降低、迭代速度极快、BOM 成本最优、监管路径最清晰。

三层系统架构

  • 第一层 · 手机层(Restora APP):四模态信号合成引擎 + 自适应算法 + UX 主流程 + 医生处方 / 患者居家全流程
  • 第二层 · NT-Hub 主控盒:数模转换 + 4 路独立驱动 + 三层安全护栏 + 模块识别(含医疗级 IEC 60601-1 安规设计)
  • 第三层 · 模块化外设:taVNS 耳夹 + NMES 肌贴 + PEMF 弹力带线圈 + LIPUS 超声探头 + 传感贴片(PPG / 阻抗 / 皮温 / IMU)

Restora's architecture rests on a critical decision: signal generation, scheduling, and personalization algorithms all reside on the phone (leveraging Aika Lab's years of accumulated core algorithm capabilities), while peripherals only handle "transduction + execution + safety protection." The benefits: dramatically lower hardware barriers, fast iteration cycles, optimal BOM costs, and the cleanest regulatory path.

Three-Tier System Architecture

  • Tier 1 · Phone Layer (Restora APP): Four-modality signal synthesis engine + adaptive algorithms + UX flows + physician prescription / patient home-use full lifecycle
  • Tier 2 · NT-Hub Controller: Digital-to-analog conversion + 4 independent drive channels + three-layer safety guardrails + module identification (medical-grade IEC 60601-1 safety design)
  • Tier 3 · Modular Peripherals: taVNS ear clip + NMES muscle patches + PEMF coil belt + LIPUS ultrasound probe + sensor patch (PPG / impedance / skin temperature / IMU)

3.2 四模态融合:全球首发 3.2 Four-Modality Fusion: A World First

Restora v1.0 是全球第一款在同一无创可穿戴产品中整合四种神经调控模态的设备:

模态物理形态作用机制
taVNS耳屏夹(立体 Ag/AgCl 电极)经皮耳迷走神经刺激 → 胆碱能抗炎通路 → 系统性消炎(IL-6/TNF-α 下降)
NMES凝胶贴片 4 片一组(5×5 cm)肌肉电刺激 → 强直收缩 → 静脉肌泵 → 改善局部血流 + 消肿 + 防肌肉萎缩
PEMF弹力带内嵌 Litz 线圈(亥姆霍兹对)脉冲电磁场(1.5/15/75 Hz)→ 成骨细胞 Ca²⁺ 信号 → 加速骨愈合 + 改善微循环
LIPUS超声探头(Φ 28mm PZT 圆盘)低强度脉冲超声(1.5 MHz)→ 机械力学转导 → 骨折愈合时间显著缩短
传感贴片贴片(5×5 cm 多传感融合)PPG(灌注)+ 生物阻抗(水肿)+ 皮温(炎症/CRPS 早警)+ 9 轴 IMU(运动/步态)

Restora v1.0 is the world's first device to integrate four neuromodulation modalities within a single non-invasive wearable:

ModalityPhysical FormMechanism
taVNSAuricular clip (stereo Ag/AgCl electrodes)Transcutaneous auricular vagus nerve stimulation → cholinergic anti-inflammatory pathway → systemic anti-inflammation (IL-6 / TNF-α reduction)
NMESGel patches in groups of 4 (5×5 cm)Muscle electrical stimulation → tetanic contraction → venous muscle pump → improved local blood flow + edema reduction + muscle atrophy prevention
PEMFElastic band with embedded Litz coil (Helmholtz pair)Pulsed electromagnetic field (1.5/15/75 Hz) → osteoblast Ca²⁺ signaling → accelerated bone healing + microcirculation improvement
LIPUSUltrasound probe (Φ 28mm PZT disc)Low-intensity pulsed ultrasound (1.5 MHz) → mechanotransduction → significantly shortened fracture healing time
Sensor PatchMulti-sensor fused patch (5×5 cm)PPG (perfusion) + bio-impedance (edema) + skin temperature (inflammation/CRPS early warning) + 9-axis IMU (movement/gait)

3.3 三层差异化壁垒 3.3 Three-Layer Differentiation Moat

壁垒一:多模态融合的技术深度

四种刺激模态的协同时序需要数千小时的参数调优;Aika Lab 团队已具备低频电脉冲、中频 PEMF、声学/超声、高频信号生成的全栈能力。后来者从零摸索,至少需要 2 年时间。

壁垒二:闭环传感算法

现有 RCT 全部使用「固定参数」协议。Restora 引入 PPG / 阻抗 / EMG 的实时闭环反馈,使治疗强度与时长根据患者个体状态自适应调节 —— 这种「个性化算法」是单纯模仿硬件无法获得的护城河。

壁垒三:临床证据先发优势

Phase A / B / C 三阶段 RCT 将系统建立骨科适应症的临床证据基础。每发表一篇高水平 RCT,竞品需要 2–3 年才能追平。这是医疗器械领域真正长效的壁垒。

Moat 1: Technical Depth of Multi-Modality Fusion

Synchronizing four stimulation modalities requires thousands of hours of parameter tuning. Aika Lab already possesses full-stack signal generation capability across low-frequency electrical pulses, mid-frequency PEMF, acoustic / ultrasound, and high-frequency signals. New entrants starting from scratch would need at least 2 years to catch up.

Moat 2: Closed-Loop Sensing Algorithms

Existing RCTs all use "fixed parameter" protocols. Restora introduces real-time closed-loop feedback via PPG / impedance / EMG, allowing treatment intensity and duration to adapt to the patient's individual state. This "personalization algorithm" is a moat that cannot be obtained by hardware imitation alone.

Moat 3: First-Mover Clinical Evidence Advantage

Phase A / B / C three-stage RCTs will systematically establish the clinical evidence base for orthopedic indications. Every high-impact RCT publication adds 2–3 years for competitors to catch up. This is the truly durable moat in medical devices.

四、商业愿景 4. Business Vision

4.1 两阶段商业化战略 4.1 Two-Phase Commercialization Strategy

Restora 不走传统医疗器械「一步到位拿证再上市」的高风险路径,而是采用业界已被验证的「先消费、后医疗」两阶段策略。这一策略已由 Parasym、Oura、Apple Watch 等先行者证明可行。

维度Phase 0 · 辅助疗愈版Phase 1 · 医疗器械版
品牌Restora RecoveryRestora Medical
产品定位肌肉舒缓 + 放松伴侣 + HRV 调节骨科术后康复(CRPS 预防 + 加速恢复)
宣称范围放松、恢复、改善睡眠、HRV、健身辅助治疗、消炎、消肿、骨愈合、CRPS 预防
监管路径US: FDA NSR / CN: 按摩器备案 / EU: 非医疗US: FDA 510(k) / CN: NMPA II 类 / EU: CE-MDR IIa
渠道DTC:电商 + 自营官网 + 跨境出海B2B2C:医院骨科 + 康复科处方 + APP 订阅
用户对象健身爱好者、白领、运动恢复人群、自主康复者骨科 / 康复科医师处方的术后患者
数据价值积累真实使用数据 + 安全性证据反哺医疗版的临床证据 + AI 训练

Restora avoids the traditional high-risk path of "regulatory approval before any market entry." Instead, we adopt the industry-proven "consumer first, medical next" two-phase strategy, validated by predecessors including Parasym, Oura, and Apple Watch.

DimensionPhase 0 · Wellness VersionPhase 1 · Medical Device Version
BrandRestora RecoveryRestora Medical
PositioningMuscle relaxation + recovery companion + HRV regulationOrthopedic post-op rehabilitation (CRPS prevention + accelerated recovery)
ClaimsRelaxation, recovery, sleep improvement, HRV, fitness adjunctTreatment, anti-inflammation, edema reduction, bone healing, CRPS prevention
RegulationUS: FDA NSR / CN: massage device filing / EU: non-medicalUS: FDA 510(k) / CN: NMPA Class II / EU: CE-MDR Class IIa
ChannelsDTC: e-commerce + own website + cross-borderB2B2C: hospital orthopedic + rehab prescription + APP subscription
UsersFitness enthusiasts, professionals, sports recovery, self-rehabPost-op patients prescribed by orthopedic / rehab physicians
Data ValueAccumulate real-world usage data + safety evidenceFeed clinical evidence + AI training for Medical version

4.2 战略意义:消费养医疗 4.2 Strategic Meaning: Consumer Fuels Medical

两阶段策略不是简单的分步上市,而是一套有机的「数据飞轮」:

  • 消费版用户的真实使用数据,是医疗版临床证据的天然「真实世界对照组」(RWE)
  • 消费版的硬件迭代经验,让医疗版避免重复试错
  • 消费版形成的品牌认知,让医疗版上市后医师与患者的接受度更高
  • 消费版产生的现金流,能够支撑医疗版的长期临床研究与监管投入

The two-phase strategy is not merely sequential market entry — it is an organic "data flywheel":

  • Real-world usage data from the consumer version naturally serves as the "real-world evidence" (RWE) control arm for the medical version's clinical research
  • Hardware iteration learnings from the consumer version help the medical version avoid repeated mistakes
  • Brand recognition built by the consumer version increases physician and patient acceptance of the medical version
  • Cash flow from the consumer version supports the long-term clinical research and regulatory investment required for the medical version

4.3 全球市场容量与增长空间 4.3 Market Sizing: TAM / SAM / SOM

层级规模说明
TAM 总市场约 280 亿美元2035 年全球神经调控市场总规模
SAM 可服务市场约 45 亿美元骨科 + 康复细分(约占总市场 16%)
SOM 可达份额约 5 亿美元5 年内中美欧三地重点市场可触达份额(约 11%)

4.4 收入与增长路径

我们对收入路径做了分场景测算(详细财务模型已纳入正式商业计划,可在签订 NDA 后向合作伙伴披露):

  • Phase 0 消费版:客单价定位 ¥800–¥1,600 区间,毛利率约 50–60%,首年目标销量达到中型保健品 / 消费电子初期水准
  • Phase 1 医疗版:设备 + 订阅模式(设备一次性 + 月度算法订阅),客单价显著高于消费版,毛利率受医院渠道与医保支付影响
  • 国际化路径:以美国市场为首发,借鉴 Theranica Nerivio 进入中国的成功路径,欧盟为长期市场
  • 增长曲线:消费版上市 9–12 个月内进入正现金流;医疗版获批后形成长期高毛利支柱业务
LevelSizeDescription
TAM (Total Market)~$28 BillionGlobal neuromodulation market size by 2035
SAM (Serviceable Market)~$4.5 BillionOrthopedic + rehabilitation sub-segment (~16% of total)
SOM (Achievable Share)~$500 MillionReachable share in CN/US/EU within 5 years (~11%)

4.4 Revenue & Growth Path

We have modeled revenue scenarios (detailed financial models are included in the formal business plan, available to partners after NDA execution):

  • Phase 0 consumer version: ASP positioned at $130–$250 range, gross margin ~50–60%, first-year volume target on par with successful early-stage health / consumer electronics brands
  • Phase 1 medical version: device + subscription model (one-time device + monthly algorithm subscription), with significantly higher ASP, gross margin influenced by hospital channels and insurance reimbursement
  • Internationalization: US-first launch, leveraging the successful Theranica Nerivio path to enter China, with EU as a long-term market
  • Growth curve: positive cash flow within 9–12 months of consumer version launch; medical version becomes long-term high-margin pillar business after approval

五、项目可行性论证 5. Feasibility Analysis

5.1 技术可行性 5.1 Technical Feasibility

核心技术已有储备。Aika Lab 团队已具备多年的算法与信号处理积累,覆盖以下关键技术能力:

  • 低频电脉冲(1–100 Hz,可驱动 TENS / NMES / taVNS)
  • 中频脉冲电磁场(1–75 Hz 脱块调制,可驱动 PEMF 线圈)
  • 声学 / 超声波(含 1.5 MHz FDA 批准频段,可拓展 LIPUS 骨愈合)
  • 手机端的算法生成与 Type-C 输出方案已成熟

这意味着 Restora 的核心技术不需要从零开始研发,而是把已有的算法能力工程化、产品化、临床化。

硬件门槛大幅降低。由于采用「手机即算法平台、外设即执行单元」的架构,硬件本身不需要承担复杂的信号合成任务,BOM 控制良好(10K 量产单价约 $40 USD),可与成熟代工体系无缝衔接。

原型路径清晰。已规划清晰的 PoC → EVT → DVT → PVT 四轮原型路径,9 个月可达可量产水准。

Core technology already in place. The Aika Lab team has accumulated years of algorithm and signal processing capability across the following key domains:

  • Low-frequency electrical pulses (1–100 Hz, capable of driving TENS / NMES / taVNS)
  • Mid-frequency pulsed electromagnetic fields (1–75 Hz block modulation, capable of driving PEMF coils)
  • Acoustic / ultrasound (including the 1.5 MHz FDA-approved band, extensible to LIPUS bone healing)
  • Phone-based algorithmic signal generation with Type-C output is mature

This means Restora's core technology does not need to be developed from scratch — we are engineering, productizing, and clinically validating capabilities already in hand.

Hardware barriers dramatically reduced. With the "phone-as-platform, peripherals-as-transducers" architecture, hardware itself doesn't need to handle complex signal synthesis. BOM is well-controlled (~$40 USD at 10K production volume), seamlessly integrating with mature contract manufacturers.

Clear prototyping path. A four-stage prototyping path (PoC → EVT → DVT → PVT) has been planned, reaching production-ready status in 9 months.

5.2 临床可行性 5.2 Clinical Feasibility

证据基础扎实。我们完成了基于 PubMed / ClinicalTrials.gov 的系统文献综述,纳入 32 篇关键 RCT 与 meta-analysis。结论是:

  • PEMF:Peng 2020 meta(22 项 RCT,n=1,468)显示愈合率 RR=1.22 [1.10–1.35]
  • LIPUS:Schofer 系统综述显示 nonunion 愈合率 82%(n=1,441)
  • NMES:TKA / THR 术后 meta 显示水肿减轻 43%(vs sham)
  • taVNS:SetPoint RESET-RA RCT(n=242)显示 ACR20 显著优于假对照(35.2% vs 24.2%)

三阶段 RCT 路径。Phase A 可行性 IIT(n≈40,6 月)→ Phase B 析因 RCT(n≈80,12 月)→ Phase C 枢轴 RCT(n≈300,多中心双盲,18 月,主要终点:12 周 CRPS 发病率降幅 ≥ 30%)。

Solid evidence base. We completed a systematic literature review across PubMed and ClinicalTrials.gov, including 32 key RCTs and meta-analyses. Key findings:

  • PEMF: Peng 2020 meta (22 RCTs, n=1,468) shows healing rate RR=1.22 [1.10–1.35]
  • LIPUS: Schofer systematic review shows 82% nonunion healing rate (n=1,441)
  • NMES: TKA / THR post-op meta shows 43% edema reduction (vs sham)
  • taVNS: SetPoint RESET-RA RCT (n=242) shows ACR20 significantly superior to sham (35.2% vs 24.2%)

Three-stage RCT pathway. Phase A feasibility IIT (n≈40, 6 months) → Phase B factorial RCT (n≈80, 12 months) → Phase C pivotal RCT (n≈300, multi-center double-blind, 18 months, primary endpoint: ≥ 30% reduction in 12-week CRPS incidence).

5.3 监管可行性 5.3 Regulatory Feasibility

三地监管路径已厘清,所有路径均有先例可循:

市场推荐路径先例 / 参照
美国 FDA510(k) 等同性(Predicate 已锁定)Parasym Plus / EXOGEN / Orthofix Physio-Stim 均已通过类似路径
欧盟 CE-MDRClass IIa MDR + 公告机构Nurosym、tVNS+ 等 taVNS 设备已 CE 标识
中国 NMPAII 类医疗器械 + 创新医疗器械绿色通道Theranica Nerivio 2025-08 获批,提供路径示范

Regulatory pathways for all three regions have been clarified, each with established precedents:

MarketRecommended PathPrecedent
USA FDA510(k) substantial equivalence (predicate identified)Parasym Plus / EXOGEN / Orthofix Physio-Stim all approved via similar paths
EU CE-MDRClass IIa MDR + notified bodyNurosym, tVNS+ and other taVNS devices already CE-marked
China NMPAClass II device + Innovation green channelTheranica Nerivio (approved 2025-08) provides path demonstration

5.4 商业可行性 5.4 Commercial Feasibility

  • 市场容量大:4 亿次年度骨折 / 骨科手术 × 30% 并发症发生率 = 巨大未满足需求
  • 现金流路径清晰:消费版 6 个月可上市并产生收入,避免长期「只投入不产出」的死亡谷
  • 用户支付意愿明确:康复设备的 C 端付费习惯已被 Theragun、Hyperice 等品牌验证
  • 品牌可继承:消费版的品牌资产可无缝迁移到医疗版,避免重复投入
  • Large market capacity: 400M annual fractures/surgeries × 30% complication rate = massive unmet need
  • Clear cash flow path: consumer version launches and generates revenue within 6 months, avoiding the long "investment-only" death valley
  • Validated willingness to pay: consumer payment habits for recovery devices already proven by brands like Theragun and Hyperice
  • Brand inheritability: consumer brand assets transfer seamlessly to medical version, avoiding duplicate investment

六、合作模式与分工 6. Partnership Model & Division of Labor

6.1 合作理念 6.1 Partnership Philosophy

我们相信:一项足够创新的医疗 / 大健康产品,需要「技术 + 产业」两种能力的深度互补。Restora 的核心创新源自团队多年的算法与信号研究,但要让这套创新真正抵达数亿患者,需要专业的产业落地、规模化生产、医疗机构合作、监管取证能力 —— 这些恰好是优秀的产业合作伙伴最擅长的部分。

因此,我们希望与合作伙伴建立战略联合而非简单的供应关系:双方在股权 / 治理 / 利益分配 / 知识产权 / 品牌等关键议题上协商一致,共同推动 Restora 成为全球骨科康复领域的标志性产品。

We believe: a truly innovative medical / digital health product requires deep complementarity between "technology + industry" capabilities. Restora's core innovation stems from the Aika Lab team's years of algorithm and signal research. But for this innovation to actually reach hundreds of millions of patients, we need professional industrialization, scaled manufacturing, healthcare partnerships, and regulatory expertise — exactly the strengths of excellent industrial partners.

Therefore, we seek to build a strategic alliance with our partners, not a simple supplier relationship. Both sides should align on equity / governance / profit sharing / IP / brand and other key issues, jointly driving Restora to become a flagship product in the global orthopedic rehabilitation landscape.

6.2 合作分工框架 6.2 Division of Labor Framework

环节我方(Aika Lab)合作伙伴方
立项研究提供完整可研报告、商业计划、研发方案(已完成)评审并提出商业化建议
核心技术系统架构设计、APP 算法、信号处理、AI 闭环、知识产权(已基本就绪 / 持续迭代)协助产品工程化、与生产工艺打通
软件研发APP(iOS / Android)、云端、医生工作站协助渠道侧 SDK 集成(如有)
ID / 结构设计提供视觉系统 brief、ID 概念草案引入 ID 工作室或自有团队完成产品级设计与模具开发
代工厂落地提供 BOM 与技术规格、配合验厂选定并管理代工厂(EMS / ODM),确保质量、成本、交期
规模化生产配合 PoC / EVT / DVT / PVT 各阶段验证主导 EVT 之后的产线建设、量产管理、品控
销售与渠道提供品牌定位、营销 brief、产品话术主导消费版电商运营、线下渠道、海外分销
医疗机构合作提供临床证据材料、KOL 沟通话术主导与三甲医院、康复中心的 BD,签订入院 / 处方协议
临床试验提供方案设计、生理标志物分析、数据处理主导 IIT 与 RCT 的临床运营、入组、中心管理
医疗器械取证提供技术文档、设计历史档案、风险管理主导 FDA 510(k) / NMPA II 类 / CE-MDR 注册流程
售后服务APP 内售后体系、远程数据支持线下售后网络、客服中心
简言之:我方提供「大脑」(系统、算法、临床证据、品牌策略),合作伙伴提供「手脚」(生产、销售、医疗渠道、监管取证)。双方深度互补,共同打造一款全球领先的智能康复产品。
FunctionAika Lab ProvidesPartner Provides
Project FoundationComplete feasibility study, business plan, R&D plan (DONE)Review and contribute commercialization advice
Core TechnologySystem architecture, APP algorithms, signal processing, AI closed-loop, IP (largely ready / continuous iteration)Assist product engineering and manufacturing process integration
Software DevelopmentAPP (iOS / Android), cloud, physician workstationAssist channel-side SDK integration (if needed)
ID / Structural DesignVisual system brief, ID concept draftsEngage ID studio or in-house team to complete production-grade design and mold development
Contract ManufacturingProvide BOM and tech specs, support factory auditSelect and manage CM (EMS / ODM), ensure quality, cost, delivery
Scaled ProductionSupport PoC / EVT / DVT / PVT validationLead production line setup, mass production management, QC after EVT
Sales & DistributionProvide brand positioning, marketing brief, product messagingLead consumer e-commerce operations, offline channels, overseas distribution
Hospital PartnershipsProvide clinical evidence materials, KOL talking pointsLead BD with tertiary hospitals and rehabilitation centers, sign procurement / prescription agreements
Clinical TrialsProvide protocol design, biomarker analysis, data processingLead IIT and RCT clinical operations, enrollment, site management
Regulatory ApprovalProvide technical documentation, design history files, risk managementLead FDA 510(k) / NMPA Class II / CE-MDR registration processes
After-Sales ServiceIn-APP service system, remote data supportOffline service network, call center
In short: Aika Lab provides the "brain" (systems, algorithms, clinical evidence, brand strategy); partners provide the "hands and feet" (manufacturing, sales, medical channels, regulatory approvals). Deep complementarity to jointly build a globally leading smart rehabilitation product.

6.3 合作形式(建议方向,可灵活商议) 6.3 Partnership Structures (Open for Discussion)

  • 形式 A · 合资公司:双方共同出资成立新公司,技术与产业资源对应股权
  • 形式 B · 战略股权 + 技术授权:合作伙伴战略入股 Aika Lab,同时获得 Restora 技术授权
  • 形式 C · 项目联合体:以项目制方式签署联合开发协议,分阶段推进
  • 形式 D · 区域代理 + 联合运营:合作伙伴负责特定区域(如中国大陆)的全面落地,享有独占权

具体形式将在双方初步对齐意向后,进入正式商务谈判阶段共同确定。

  • Option A · Joint Venture: Both sides co-invest in a new entity, with technology and industrial resources mapped to equity stakes
  • Option B · Strategic Equity + Technology License: Partner takes strategic equity in Aika Lab while receiving Restora technology license
  • Option C · Project Consortium: Sign joint development agreement on project basis, advancing in phases
  • Option D · Regional Agency + Joint Operation: Partner takes exclusive rights for specific regions (e.g., Mainland China) with full local execution

The specific structure will be jointly determined during formal business negotiations after initial alignment of intent.

七、我方已完成的工作 7. What We Have Already Completed

作为对合作伙伴的诚意承诺,我方在邀请合作之前已完成完整的立项研究包。以下八份核心文档可在签订 NDA 后向合作伙伴完整披露:

#文档核心内容
01国际竞争分析报告(14 页 PPT)12 家国际玩家 + 5 大技术路线 + 3 大监管市场对标
02文献综述(15 页 PPT)32 篇 RCT / meta-analysis 系统综述,证据等级矩阵
03产品 PRD v0.1(15 页 PPT)产品愿景、用户画像、用户旅程、产品定义、监管策略
04初步设计方案(16 页 PPT)系统架构、信号链路、安全架构、ID 概念、APP UX、BOM
05采购指南(Markdown)对标品评估、OEM 供应商联系方式、第一周采购清单
06视觉系统 Brief(Markdown)品牌内核、色彩系统、Logo 方向、字体、Tone of voice
07两阶段商业化策略(15 页 PPT)消费版 / 医疗版双轨细化、监管路径、衔接策略
08投资人 Pitch Deck(16 页 PPT)融合品牌 + 两阶段策略 + 全部研究成果的完整路演材料

As a demonstration of our commitment to potential partners, we have completed a comprehensive project foundation package before extending this invitation. The following eight core documents are available for full disclosure to partners after NDA execution:

#DocumentCore Content
01International Competitive Analysis (14-page PPT)12 international players + 5 technology tracks + 3 regulatory markets benchmarking
02Literature Review (15-page PPT)32 RCTs / meta-analyses systematically reviewed, evidence-level matrix
03Product PRD v0.1 (15-page PPT)Vision, personas, user journey, product definition, regulatory strategy
04Preliminary Design (16-page PPT)System architecture, signal chain, safety, ID concept, APP UX, BOM
05Procurement Guide (Markdown)Benchmark product evaluations, OEM supplier contacts, week-1 procurement list
06Visual System Brief (Markdown)Brand essence, color system, logo direction, typography, tone of voice
07Two-Phase Commercialization Strategy (15-page PPT)Consumer / medical dual-track detail, regulatory paths, transition strategy
08Investor Pitch Deck (16-page PPT)Brand + two-phase strategy + all research findings — full pitch material

八、合作伙伴画像 8. Partner Profile

8.1 优先合作对象 8.1 Priority Partner Categories

  • 已建立医疗器械 / 健康消费品产业链的企业:拥有成熟代工资源、品控体系、注册经验
  • 拥有医院 / 康复机构渠道网络的企业或个人:能够推动产品进入三甲骨科 / 康复科
  • 熟悉 FDA 510(k) / NMPA II 类 / CE-MDR 注册流程的产业方
  • 具备消费医疗 / 大健康品牌运营能力的企业:电商 + DTC + 线下渠道齐全
  • 有意向进入神经调控 / 智能康复赛道的产业资本
  • 具备远见与执行力的连续创业者:愿意把「产业落地」作为自己的核心使命
  • Enterprises with established medical device / health consumer goods supply chains: mature CM resources, QC systems, regulatory experience
  • Enterprises or individuals with hospital / rehabilitation channel networks: able to drive adoption in tertiary orthopedic / rehab departments
  • Industrial partners familiar with FDA 510(k) / NMPA Class II / CE-MDR registration processes
  • Enterprises with consumer medical / digital health brand operation capabilities: e-commerce + DTC + offline channels
  • Industrial capital with intent to enter the neuromodulation / smart rehabilitation space
  • Serial entrepreneurs with vision and execution: willing to treat "industrial execution" as their core mission

8.2 我们看重的合作伙伴特质 8.2 Qualities We Value in a Partner

  • 战略眼光:能够理解「消费养医疗」两阶段策略的长远价值,而不仅着眼短期收益
  • 执行能力:拥有把产品从原型推进到量产、销售、入院的实际落地经验
  • 产业资源:在制造、销售、医疗渠道、监管中至少有一项深度积累
  • 协同意愿:愿意与技术团队深度配合,共同打磨产品,而非把项目当作单纯的代工或代理生意
  • 长期主义:理解医疗器械需要 24–36 个月的研发周期,愿意以「长期合伙人」心态参与
  • Strategic vision: understands the long-term value of the "consumer fuels medical" two-phase strategy, not just short-term returns
  • Execution capability: real experience driving products from prototype to mass production, sales, and hospital adoption
  • Industrial resources: deep accumulation in at least one of manufacturing, sales, medical channels, or regulatory
  • Collaboration willingness: willing to work deeply with the technical team to polish the product, not treating the project as simple CM or distribution business
  • Long-termism: understands medical devices require 24–36 month development cycles, willing to engage as a "long-term partner"

8.3 我们能为合作伙伴带来的价值 8.3 What We Bring to the Partnership

  • 一个已经完成立项研究、技术储备、品牌策略的「全栈」项目 —— 大幅降低产业落地的前置风险
  • 全球首发的「无创 × 四模态 × 骨科康复」独特产品定位 —— 5–8 年的市场窗口
  • 基于「消费养医疗」两阶段策略 —— 9 个月内即可看到现金流,无需漫长等待
  • 中美欧三地同步监管路径 —— 天然的国际化潜力
  • 一个已经具备多年神经调控算法积累的核心技术团队
  • A "full-stack" project with completed foundation research, technology reserves, and brand strategy — dramatically reducing front-loaded execution risks
  • Globally first-mover positioning in "non-invasive × four-modality × orthopedic recovery" — a 5–8 year market window
  • Based on the "consumer fuels medical" two-phase strategy — cash flow within 9 months, no long waiting period
  • Synchronized regulatory pathways in CN / US / EU — natural internationalization potential
  • A core technical team with years of accumulated neuromodulation algorithm expertise

九、后续流程 9. Next Steps

9.1 建议的接洽步骤 9.1 Recommended Engagement Steps

  • 第一步 · 双方初步沟通 —— 电话 / 视频会议,了解彼此基本情况与合作意愿(1–2 周)
  • 第二步 · 签订双向 NDA —— 保密协议签署后,我方向合作伙伴完整披露八份立项文档(1 周)
  • 第三步 · 实地交流 —— 合作伙伴参观我方实验室与原型,我方了解合作伙伴的产业能力(2 周)
  • 第四步 · 意向条款协商 —— 围绕合作形式、股权 / 利益分配、知识产权、品牌使用、责任分工等核心议题协商(2–4 周)
  • 第五步 · 签订正式协议 —— 根据双方意向,可签署 LOI(合作意向书)→ MoU(合作备忘录)→ 正式合作协议
  • 第六步 · 联合启动 —— 成立联合工作组,按 PoC / EVT / DVT / PVT 节奏推进项目
  • Step 1 · Initial communication — phone / video meeting to understand each side's basics and intent (1–2 weeks)
  • Step 2 · Mutual NDA — after signing, we provide full disclosure of the eight foundation documents to the partner (1 week)
  • Step 3 · On-site exchange — partner visits our lab and prototypes; we learn the partner's industrial capabilities (2 weeks)
  • Step 4 · Term sheet negotiation — discuss partnership structure, equity / profit sharing, IP, brand use, responsibility split, and other core issues (2–4 weeks)
  • Step 5 · Formal agreement — depending on alignment: LOI (Letter of Intent) → MoU (Memorandum of Understanding) → formal partnership agreement
  • Step 6 · Joint kickoff — establish joint working group, advance project on PoC / EVT / DVT / PVT cadence

9.2 时间节奏建议 9.2 Timing Cadence

我们希望在 2026 年内完成合作伙伴的初步锁定,并在 2026 年下半年共同启动 PoC 工作。这一节奏将让 Restora 能够借助 2026–2027 年的产业窗口期,成为骨科康复神经干预领域的首发者。

We aim to identify our partner during 2026, and jointly launch PoC work in the second half of 2026. This cadence positions Restora to capitalize on the 2026–2027 industry window and become the first-mover in orthopedic rehabilitation neuromodulation.

9.3 联系方式 9.3 Contact Information

项目方
Aika Lab · AI Player in Gothenburg, Sweden
联系邮箱
联系电话 / 微信
详谈时提供
文档版本
v0.1 · 2026 年 5 月
From
Aika Lab · AI Player in Gothenburg, Sweden
Email
Phone / WeChat
Available upon initial contact
Document Version
v0.1 · May 2026

结 语

从一个朴素的临床问题出发 —— 「我们能否帮助骨折与术后患者更快、更安全地回到正常生活?」 —— Aika Lab 团队已经走完了从命题到立项的完整旅程。

但我们清楚地知道:一项真正改变医疗格局的产品,不是某一个团队凭一己之力能完成的。它需要「技术 + 产业 + 临床 + 监管」四种力量的合力。我们已经准备好了第一种力量,现在以最大的诚意,邀请您加入这场长期的、有意义的、有价值的合作。

我们相信:未来三到五年,全球神经调控 + 智能康复领域会出现一两家代表性公司。我们想与您一起,让 Restora 成为其中之一。

—— Aika Lab 项目团队
2026 年 5 月 · 瑞典哥德堡

Closing

Starting from a simple clinical question — "Can we help fracture and post-op patients return to normal life faster and more safely?" — the Aika Lab team has completed the full journey from premise to launch-ready project.

But we know clearly: a product that truly changes the medical landscape cannot be built by any single team alone. It requires the combined force of "technology + industry + clinical + regulatory." We have prepared the first force; now, with the deepest sincerity, we invite you to join this long, meaningful, and valuable collaboration.

We believe: in the next 3–5 years, one or two flagship companies will emerge in global neuromodulation + smart rehabilitation. We want to work with you to make Restora one of them.

—— The Aika Lab Project Team
May 2026 · Gothenburg, Sweden

保密提示 / Confidentiality

本文件包含 Aika Lab 团队的未公开商业策略、技术方案与项目规划。仅限受邀对话伙伴查阅。在签订正式 NDA 之前,请勿向第三方披露、转发或复制。文件内容如有更新,以最新版本为准。

This document contains Aika Lab's unpublished commercial strategy, technical solutions, and project planning. Restricted to invited dialogue partners only. Before signing a formal NDA, please do not disclose, forward, or copy to any third party. The latest version supersedes prior content.

© 2026 Aika Lab · hello@aikalab.se · Gothenburg, Sweden

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